Controlled steering functionality for implant-delivery tool

ABSTRACT

An apparatus can include: (1) a steerable tube, having a proximal section, a distal section, and a central longitudinal axis, the tube defining a primary lumen and two secondary lumens; (2) two wires, each extending from the distal section proximally through a respective secondary lumen; (3) a handle, coupled to the proximal section, and including a steering knob that is coupled to the wires such that rotation of the knob adjusts a degree of tension in the wires; (4) a pull ring coupled to the distal section of the tube such that the pull ring circumscribes the longitudinal axis at the distal section of the tube, and defining two recesses, a distal end portion of each wire being disposed in a respective one of the recesses; and (5) at least one cap, bridging the recesses and the distal end portion of the wires. Other embodiments are also described.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a Continuation of U.S. Ser. No. 14/357,040 toSheps et al., entitled “Controlled steering functionality forimplant-delivery tool,” which published as US 2014/0309661, and which isthe US National Phase of PCT application IL2012/050451 to Sheps et al,entitled “Controlled steering functionality for implant-delivery tool,”filed Nov. 8, 2012, which published as WO 2013/069019, and which claimspriority from U.S. Provisional Patent Application 61/557,082 to Sheps etal., entitled “Controlled steering functionality for implant-deliverytool,” filed Nov. 8, 2011, each of which is incorporated by reference.

FIELD OF THE INVENTION

The present invention relates in general to valve repair. Morespecifically, the present invention relates to repair of a cardiac valveof a patient using a steerable delivery tool.

BACKGROUND

Steerable catheters are typically used to access a body cavity of apatient since these steerable catheters are able to navigate throughvasculature of the patient. Additionally, pre-shaped sheaths are used todeliver an implant to the body cavity in a particular orientation.

SUMMARY OF THE INVENTION

In some applications of the present invention, a multi-component tubularsystem is provided for accessing a heart of a patient. The systemcomprises one or more steerable guiding catheters configured fordirecting the passage of devices therethrough into the heart.

The multi-component tubular system is configured to deliver an implantin a desired orientation to an annulus of a cardiac valve of the patientand to facilitate anchoring of the implant to the annulus. For someapplications of the present invention, the guiding system is advancedtransluminally or transthoracically accessing an atrium of the heart.Typically, the system comprises two or more steerable catheters. A firstcatheter has a distal portion that is steerable to a first desiredspatial orientation. A second catheter is disposed within the firstcatheter and has a distal portion that is steerable to a second desiredspatial orientation. The system provides techniques andrelative-spatial-orientation-controlling devices for controlling theorientation of the distal portion of the second catheter with respect tothe first catheter without substantially distorting the first spatialorientation of the distal portion of the first catheter. For someapplications, the relative-spatial-orientation-controlling devicecomprises a rotational locking mechanism provided by components of thecatheter system.

For some applications, the first catheter is configured to provide aslit at the distal portion thereof (i.e., a first component of therotational locking mechanism), and the second catheter is configured toprovide a depressible pin (i.e., a second component of the rotationallocking mechanism) at a distal portion thereof. The second catheter isconfigured for advancement through a lumen of the first catheter. Duringthe advancement, the pin is depressed by an inner wall of the firstcatheter. The pin is configured to return to a resting state in whichthe pin is not depressed, when the pin is aligned with the slit of thefirst catheter. Since the first catheter provides the slit at a distalportion thereof, the second catheter may be introduced within the lumenof the first catheter in any suitable rotational orientation withrespect to the first catheter.

The distal portion of the first catheter may be steered in a suitabledirection following advancement of the first catheter throughvasculature of the patient. Following the advancement of the firstcatheter and steering of the distal portion of the first catheter in anyone or more suitable planes, the second catheter is advanced through thefirst catheter. The second catheter is advanced through the firstcatheter until at least a distal-most portion of the distal portion ofthe second catheter is exposed from within the lumen of the firstcatheter. Depending on the relative rotational orientation of the secondcatheter with respect to the first catheter, the physician may need torotate the second catheter in order to engage the pin with the slit andlock the second catheter with respect to the first catheter. Suchlocking enables steering of the distal portion of the second in any oneor more suitable planes with respect to the distal portion of the firstcatheter in a manner which substantially maintains the spatialorientation of the first catheter during the steering of the secondcatheter. Additionally, the first catheter may be further steeredwithout substantially disrupting the spatial orientation of the distalportion of the second catheter.

There is therefore provided, in accordance with an application of thepresent invention, apparatus for percutaneous access to a body of apatient, including:

a first steerable tube, having a proximal end and a distal end, andshaped to define:

-   -   a first lumen between the proximal end and the distal end, and    -   a first coupling at a longitudinal site of the first steerable        tube; and

a second steerable tube, shaped to define a second lumen and a secondcoupling, the second coupling being intracorporeally couplable to thefirst coupling,

the apparatus having:

-   -   an unlocked state in which at least the second coupling is        disposed within the first lumen, and the second steerable tube        is rotatable within the first lumen, and    -   a locked state in which the second coupling is coupled to the        first coupling, the coupling of the second coupling to the first        coupling inhibiting rotation of the second steerable tube within        the first lumen, and

the apparatus being configured such that:

-   -   the second coupling is advanceable through the first lumen until        at least the longitudinal site,    -   the apparatus remains in the unlocked state when the second        coupling is disposed within the first lumen, proximal to the        longitudinal site, and    -   when the second coupling becomes disposed at the longitudinal        site in a given rotational orientation of the second steerable        tube within the first lumen, the apparatus moves into the locked        state by the second coupling automatically coupling to the first        coupling.

In an application, when the apparatus is in the locked state, the secondsteerable tube has a distal steering portion that is exposed from thedistal end of the first steerable tube. In an application, the secondcoupling is advanceable through the first lumen until at least thelongitudinal site, in any rotational orientation of the second steerabletube with respect to the first steerable tube.

In an application:

the first coupling has a longitudinal length that is less than 30% of alongitudinal length of the first steerable tube,

the second coupling has a longitudinal length that is less than 30% of alongitudinal length of the second steerable tube, and

the second steerable tube is couplable to the first steerable tube bythe second coupling being couplable to the first coupling.

In an application, the first coupling has a longitudinal length that isless than 2% of the longitudinal length of the first steerable tube, andthe second coupling has a longitudinal length that is less than 2% ofthe longitudinal length of the second steerable tube.

In an application:

the first steerable tube includes a respective first pull ring and arespective first pair of pull wires, and the second steerable tubeincludes a respective and a respective second pair of pull wires,

each of the pull rings is disposed at a respective distal steerableportion of the respective steerable tube, and

each pull wire of each pair of pull wires is coupled to the respectivepull ring thereof, and extends within a wall of the respective steerabletube, proximally from the respective pull ring.

In an application, the apparatus is configured such that, when theapparatus is in the locked state thereof, a plane on which the firstpair of pull wires lies is generally orthogonal to a plane on which thesecond pair of pull wires lies.

In an application:

each pull ring is shaped to define at least two recesses, a distalportion of each pull wire being disposed in a respective recess, thedisposition in the respective recess facilitating the coupling of thepull wire to the pull ring.

In an application, the apparatus further includes a plurality of caps,and at least one of the caps is coupled to each pull ring such that theat least one cap bridges at least one of the recesses and the distal endportion of at least one pull wire, the coupling of the at least one capto the pull ring facilitating the coupling of the pull wire to the pullring.

In an application, the distal steerable portion of at least one of thesteerable tubes selected from the group consisting of the firststeerable tube and the second steerable tube includes amultiple-durometer section, the multiple-durometer section including:

a distal pull-ring section, the first pull-ring being coupled to thedistal pull-ring section;

a bending section, proximal to the distal pull-ring section, and moreflexible than the distal pull-ring section; and

a transition section, between the distal pull-ring section and thebending section, and being more flexible than the distal pull-ringsection and less flexible than the bending section.

In an application:

the selected steerable tube includes a uniform-durometer section,proximal to the multiple-durometer section,

the transition section includes a first transition section, and

the selected steerable tube includes a second transition section betweenthe bending section and the uniform-durometer section, the secondtransition section being more flexible than the uniform-durometersection and less flexible than the bending section.

In an application, the apparatus further includes an extracorporeallocking system, including a protrusion and a housing, and:

the housing is shaped to define a groove, and

the protrusion is configured to be coupled to the housing by beingdisposed in the groove, and

the apparatus is configured such that the coupling of the protrusion tothe housing facilitates the inhibition of the rotation of the secondsteerable tube within the first lumen.

In an application:

the apparatus further includes a first handle, coupled to the firststeerable tube, and a second handle, coupled to the second steerabletube,

one of the handles selected from the group consisting of the firsthandle and the second handle, includes the housing,

one of the handles selected from the group consisting of the firsthandle and the second handle, includes the housing, and

the protrusion is configured to be coupled to the housing by the firsthandle being coupled to the second handle.

In an application, the apparatus further includes a stand that includesa track, and the first handle and the second handles are independentlyslidably coupled to the track.

In an application, the apparatus further includes at least oneextracorporeal indicator, coupled to the second steerable tube,configured to move correspondingly with the second coupling, and toprovide an indication of an intracorporeal position of the secondcoupling with respect to the first steerable tube.

In an application, the second coupling is configured to revolve around alongitudinal axis of the second steerable tube in response to rotationof the second steerable tube, and the extracorporeal indicator isconfigured to revolve around the axis correspondingly with the secondcoupling.

In an application, the second coupling is configured to movelongitudinally in response to longitudinal movement of the secondsteerable tube, and the extracorporeal indicator is configured to movelongitudinally correspondingly with the second coupling.

In an application, the apparatus further includes an extracorporeallocking system, including the extracorporeal indicator and a housing,the housing being coupled to the first steerable tube, and the apparatusbeing configured such that a juxtaposition of the housing and theextracorporeal indicator corresponds to a juxtaposition of the firstcoupling and the second coupling.

In an application:

the extracorporeal indicator includes a protrusion,

the housing is shaped to define a groove configured to receive theprotrusion, and

the protrusion is configured to be coupled to the housing by beingdisposed in the groove, the coupling of the protrusion to the housing:

-   -   facilitating the inhibition of the rotation of the second        steerable tube within the first lumen, and    -   providing an extracorporeal indication that the second coupling        is coupled to the first coupling.

In an application, at least one of the couplings selected from the groupconsisting of the first coupling and the second coupling, is shaped todefine a receptacle, and at least one of the couplings selected from thegroup consisting of the first coupling and the second coupling is shapedto define a protrusion configured to be disposed within the receptacle,the protrusion being configured:

in the unlocked state of the apparatus, to be depressed by a proximityof an inner wall of the first steerable tube to an outer wall of thesecond steerable tube, and

to automatically move into the receptacle when the second coupling isdisposed within the first lumen at the longitudinal site and the secondsteerable tube is in the given rotational orientation.

In an application, the receptacle has a length of between 5 and 15 mm.

In an application, the protrusion has a length of between 2 and 3 mm.

In an application, when the apparatus is in the locked state, the secondcoupling is axially slidable with respect to the first coupling bygreater than 5 mm and less than 15 mm.

In an application, when the apparatus is in the locked state, the secondsteerable tube has an exposed distal steering portion that is exposedfrom the distal end of the first steerable tube, and the slidability ofthe second coupling with respect to the first coupling facilitates theexposed distal steering portion having a variable length, the variablelength having a smallest length of 25 mm and a greatest length of 35 mm.

There is further provided, in accordance with an application of thepresent invention, apparatus for percutaneous access to an anatomicalsite of a body of a patient, including:

a first catheter, having an outer diameter of no more than 9 mm, andbeing shaped to define a first lumen therethrough, a distal end of thefirst catheter:

-   -   being transluminally advanceable to a vicinity of the anatomical        site, and    -   being bendable in a first plane;

a second catheter, shaped to define a second lumen therethrough, adistal end of the second catheter:

-   -   being advanceable through the first lumen and out of a distal        end of the first lumen,    -   when disposed outside the distal end of the first lumen, being        bendable in a second plane;

an implant, having an inner wall, and being disposable within at leastthe distal end of the second catheter;

a reference-force tube:

-   -   being shaped to define a third lumen,    -   being configured to move the implant through the distal end of        the second lumen, and    -   having a distal end that is advanceable through at least the        distal end of the second lumen;

a channel:

-   -   disposed at least in part within the third lumen,    -   shaped to define a fourth lumen, the fourth lumen being        configured to provide fluid communication therethrough between a        proximal end of the channel and the inner wall of the implant,        and    -   having a distal end that is disposed within the implant, the        distal end being configured to be slidable out of the implant;

at least one anchor, configured to be delivered to the inner wall of theimplant via the fourth lumen; and

a deployment manipulator:

-   -   including an anchor driver, and a deployment element, disposed        at a distal end of the anchor driver, and configured to be        reversibly couplable to the anchor, and    -   being configured to advance the anchor through the fourth lumen        and through the inner wall of the implant.

In an application, the fourth lumen has a transverse cross-sectionaldiameter of at least 2.5 mm.

In an application, the implant is shaped to define a lumen, thereference-force tube is shaped to define a lumen, and the lumen of thereference-force tube is in fluid communication with the lumen of theimplant.

In an application, the anchor driver is shaped to define a fifth lumen,and the apparatus further includes a rod, configured to be slidablewithin the fifth lumen so as to facilitate the reversible coupling ofthe deployment element to the anchor.

In an application, the deployment element, the anchor, and the rod areconfigured such that, when the deployment element is coupled to theanchor, proximal movement of the rod facilitates decoupling of thedeployment element from the anchor.

In an application, the distal end of the second catheter is advanceablethrough the first lumen in any rotational orientation with respect tothe first catheter, and the second catheter is couplable to the firstcatheter such that rotation of the second catheter within the firstlumen is inhibited.

In an application, the second plane is generally orthogonal to the firstplane, and the second catheter is couplable to the first catheter suchthat the distal end of the second catheter is bendable in the secondplane that is generally orthogonal to the first plane.

In an application, the apparatus is configured such that the coupling ofthe second catheter to the first catheter reduces an effect of bendingof the distal end of the second catheter on the rotational orientationof the distal end of the second catheter with respect to the firstcatheter.

In an application:

the first catheter is shaped to define a first coupling, having alongitudinal length that is less than 30% of a longitudinal length ofthe first catheter,

the second catheter is shaped to define a second coupling, having alongitudinal length that is less than 30% of a longitudinal length ofthe second catheter, and

the second catheter is couplable to the first catheter by the secondcoupling being couplable to the first coupling.

In an application, the first coupling has a longitudinal length that isless than 2% of the longitudinal length of the first catheter, and thesecond coupling has a longitudinal length that is less than 2% of thelongitudinal length of the second catheter.

In an application:

the first catheter includes a lateral wall that defines the first lumen,

the second catheter includes a lateral wall that defines the secondlumen, and

any lateral opening in the lateral wall of a catheter selected from thegroup consisting of the first catheter and the second catheter, is anopening defined by at least one of the couplings selected from the groupconsisting of the first coupling and the second coupling.

In an application:

the first catheter includes a lateral wall that defines the first lumen,

the second catheter includes a lateral wall that defines the secondlumen, and

any protrusion from the lateral wall of a catheter selected from thegroup consisting of the first catheter and the second catheter, is aprotrusion defined by at least one of the couplings selected from thegroup consisting of the first coupling and the second coupling.

In an application, the apparatus further includes at least oneextracorporeal indicator, coupled to the second catheter, configured tomove correspondingly with the second coupling, and to provide anindication of an intracorporeal position of the second coupling withrespect to the first catheter.

In an application, the second coupling is configured to revolve around alongitudinal axis of the second catheter in response to rotation of thesecond catheter, and the extracorporeal indicator is configured torevolve around the axis correspondingly with the second coupling.

In an application, the second coupling is configured to movelongitudinally in response to longitudinal movement of the secondcatheter, and the extracorporeal indicator is configured to movelongitudinally correspondingly with the second coupling.

In an application, the apparatus further includes an extracorporeallocking system, including the extracorporeal indicator and a housing,the housing being coupled to the first catheter, and the apparatus beingconfigured such that a juxtaposition of the housing and theextracorporeal indicator corresponds to a juxtaposition of the firstcoupling and the second coupling.

In an application:

the extracorporeal indicator includes a protrusion,

the housing is shaped to define a groove configured to receive theprotrusion, and

the protrusion is configured to be coupled to the housing by beingdisposed in the groove, the coupling of the protrusion to the housing:

-   -   facilitating the inhibition of the rotation of the second        catheter within the first lumen, and    -   providing an extracorporeal indication that the second coupling        is coupled to the first coupling.

In an application, the apparatus further includes at least oneextracorporeal indicator, configured to move correspondingly with theimplant, and to provide an indication of an intracorporeal position ofthe implant with respect to the second catheter.

In an application, the extracorporeal indicator is coupled to thereference-force tube, and is configured provide an indication of anintracorporeal state of deployment of the implant from the distal end ofthe second catheter.

In an application, the apparatus further includes an extracorporeallocking system, including a protrusion and a housing, and:

the housing is shaped to define a groove, and

the protrusion is configured to be coupled to the housing by beingdisposed in the groove, and

the apparatus is configured such that the coupling of the protrusion tothe housing inhibits rotation of the second catheter within the firstlumen.

In an application:

the apparatus further includes a first handle, coupled to the firstcatheter, and a second handle, coupled to the second catheter,

one of the handles selected from the group consisting of the firsthandle and the second handle, includes the housing,

one of the handles selected from the group consisting of the firsthandle and the second handle, includes the housing, and

the protrusion is configured to be coupled to the housing by the firsthandle being coupled to the second handle.

In an application, the apparatus further includes a stand that includesa track, and the first handle and the second handles are independentlyslidably coupled to the track.

In an application:

the first catheter includes a respective first pull ring and arespective first pair of pull wires, and the second catheter includes arespective and a respective second pair of pull wires,

each of the pull rings is disposed at a respective distal steerableportion of the respective catheter, and

each pull wire of each pair of pull wires is coupled to the respectivepull ring thereof, and extends within a wall of the respective catheter,proximally from the respective pull ring.

In an application:

each pull ring is shaped to define at least two recesses, a distalportion of each pull wire being disposed in a respective recess, thedisposition in the respective recess facilitating the coupling of thepull wire to the pull ring.

In an application, the apparatus further includes a plurality of caps,and at least one of the caps is coupled to each pull ring such that theat least one cap bridges at least one of the recesses and the distal endportion of at least one pull wire, the coupling of the at least one capto the pull ring facilitating the coupling of the pull wire to the pullring.

In an application, the distal steerable portion of at least one of thecatheters selected from the group consisting of the first catheter andthe second catheter, includes a multiple-durometer section, themultiple-durometer section including:

a distal pull-ring section, the first pull-ring being coupled to thedistal pull-ring section;

a bending section, proximal to the distal pull-ring section, and moreflexible than the distal pull-ring section; and

a transition section, between the distal pull-ring section and thebending section, and being more flexible than the distal pull-ringsection and less flexible than the bending section.

In an application:

the selected catheter includes a uniform-durometer section, proximal tothe multiple-durometer section,

the transition section includes a first transition section, and

the selected catheter includes a second transition section between thebending section and the uniform-durometer section, the second transitionsection being more flexible than the uniform-durometer section and lessflexible than the bending section.

There is further provided, in accordance with an application of thepresent invention, a method for use with a native atrioventricular valveof a heart of a subject, the method including:

transluminally advancing a first steerable tube toward the heart, thefirst steerable tube being shaped to define a first lumen and a firstcoupling;

bending at least a distal portion of the first steerable tube;

advancing a second steerable tube through the first lumen, while thesecond steerable tube is rotatable within the first lumen, such that adistal portion of the second steerable tube emerges from a distal end ofthe first steerable tube, the second steerable tube being shaped todefine a second lumen and a second coupling;

after at least part of the distal portion of the second steerable tubeis exposed from the distal end of the first steerable tube and isdisposed within a chamber of the heart, aligning the second couplingwith the first coupling by moving the second steerable tube with respectto the first steerable tube, such that the second coupling automaticallycouples to the first coupling; and

while the second coupling is coupled to the first coupling, bending thedistal portion of the second steerable tube toward the nativeatrioventricular valve of the subject.

There is further provided, in accordance with an application of thepresent invention, apparatus configured for providing access through asubject's skin, including:

a first steerable tube having a first lumen, the first steerable tubeshaped to define a first coupling; and

a second steerable tube having a second lumen, the second steerable tubebeing configured to be concentrically disposed within the first lumen ofthe first steerable tube, the second steerable tube being shaped todefine a second coupling; and:

-   -   at least one coupling selected from the group consisting of: the        first coupling and the second coupling, has a longitudinal        length that is less than 20 cm,    -   the first and second couplings are selectively engageable so as        to facilitate:        -   introducing of the second steerable tube within the first            lumen in any suitable rotational orientation of the second            steerable tube with respect to the first steerable tube, and        -   axial sliding of the second steerable tube with respect to            the first steerable tube, and    -   the first and second couplings are configured, when engaged and        during steering of a distal steerable portion of the second        steerable tube, to (1) generally maintain a spatial orientation        of a distal steerable portion of the first steerable tube,        and (2) minimize an effect of the spatial orientation of the        distal steerable portion of the first steerable tube on the        steering of the distal steerable portion of the second steerable        tube.

In an application, the first coupling has a proximal-most end that isdisposed up to 100 mm from a distal end of the first steerable tube.

In an application, the second coupling has a proximal-most end that isdisposed up to 120 mm from a distal end of the second steerable tube.

In an application:

at least one of the couplings selected from the group consisting of thefirst coupling and the second coupling is shaped to define a receptacle,

at least one of the couplings selected from the group consisting of thefirst coupling and the second coupling is shaped to define a protrusionconfigured to be disposed within the receptacle.

In an application, the receptacle has a length of between 5 and 15 mm.

In an application, the protrusion has a length of between 2 and 3 mm.

In an application, the protrusion is (1) depressible when surrounded byan inner wall of the first steerable tube that defines the first lumen,and (2) protrudable into the receptacle when aligned with thereceptacle.

In an application, when the first and second couplings are engaged, thesecond steerable tube is axially slidable with respect to the firststeerable tube by greater than 5 mm and less than 15 mm.

In an application, when the first and second couplings are engaged, thesecond steerable tube has an exposed-distal-steering portion that isexposed from the first steerable tube, and the second steerable tube isaxially slidable with respect to the first steerable tube such that alength of the exposed-distal-steering portion is adjustable to bebetween 25 and 35 mm.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-2 are schematic illustrations of multi-component tubular systemfor delivering and anchoring an implant and for controlling a relativespatial orientation of components of the catheter system, in accordancewith some applications of the present invention;

FIGS. 3A-E are schematic illustrations of cross-sectional images ofcomponents of the catheter system of FIGS. 1-2, in accordance with someapplications of the present invention;

FIGS. 4-6 are schematic illustrations of components of the cathetersystem of FIGS. 1-2, in accordance with some applications of the presentinvention;

FIGS. 7A-B are schematic illustrations of components of the cathetersystem of FIGS. 1-2, in accordance with some other applications of thepresent invention;

FIGS. 8-9 and 10A-C are schematic illustrations of respectiverelative-spatial-orientation-controlling devices of components of amulti-component tubular system, in accordance with respectiveapplications of the present invention;

FIGS. 11A-B are schematic illustrations of a steerable catheter havingmultiple variable steering segments, in accordance with someapplications of the present invention;

FIGS. 12A-B are schematic illustrations of a rotating deployment elementof an anchor deployment system in radially-expanded andradially-compressed states, respectively, in accordance with someapplications of the present invention;

FIGS. 13A-B are schematic illustrations of the rotating deploymentelement of FIGS. 12A-B engaging a tool-engaging head of a tissue anchor,with the element in locked and unlocked states, respectively, inaccordance with some applications of the present invention;

FIGS. 14A-I are schematic illustrations of a procedure for implanting anannuloplasty ring structure to repair a mitral valve, in accordance withsome applications of the present invention;

FIG. 15 is a schematic illustration of a procedure for implanting anannuloplasty ring structure to repair a tricuspid valve, in accordancewith some applications of the present invention;

FIGS. 16A-B are schematic illustrations of a configuration of an anchordeployment system, in accordance with some applications of the presentinvention;

FIG. 17 is a schematic illustration of components of a rotationaladjusting mechanism, in accordance with some applications of the presentinvention;

FIGS. 18A-D are schematic illustrations of an indicator and lockingsystem comprising a protrusion and a housing, or cradle, shaped todefine a groove, in accordance with some applications of the presentinvention;

FIGS. 19A-B are schematic illustrations of a sleeve-deploymentindicator, in accordance with some applications of the presentinvention; and

FIG. 20 is a schematic illustration of a system for coupling a pull ringof a catheter to pull wires, in accordance with some applications of theinvention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is now made to FIGS. 1-2, which are schematic illustrations ofa multi-component tubular system 10 providing one or morerotationally-controlled steering catheters configured for delivering animplant to a heart of a patient, in accordance with some applications ofthe present invention. System 10 provides an implant-delivery tool.Typically, system 10 comprises a first, outer catheter 12 comprising asheath (i.e., a lateral wall that defines a lumen) configured foradvancement through vasculature of a patient. For some applications ofthe present invention, outer catheter 12 comprises a sheath configuredfor advancement through a femoral artery toward an interatrial septum ofa heart of a patient. A distal steerable end portion of outer catheter12 is configured to pass through the septum and be oriented in a desiredspatial orientation. System 10 comprises a second catheter, or guidecatheter 14, comprising a steerable distal end portion. Catheter 14comprises a sheath (i.e., a lateral wall that defines a lumen), and isconfigured for advancement through the lumen of outer catheter 12. Outercatheter 12 provides a first coupling 152 (e.g., a receptacle, such asan opening, such as a slit 52) at a distal portion of the lateral wallthereof (e.g., a portion of catheter 12 that is proximal to thesteerable distal end portion). Guide catheter 14 comprises a secondcoupling 154 (e.g., a protrusion, such as a depressible engager 54) thatis coupled to a displaceable tab 56 coupled to a base. As is describedherein, depressible engager 54 (or the second coupling 154) isconfigured so as to protrude within slit 52 (or the first coupling 152).Thus, slit 52 defines a second-coupling-receiving element.

First coupling 152 of catheter 12 defines a longer coupling, the secondcoupling 154 of catheter 14 defines a shorter coupling. The first andsecond couplings 152 and 154 of outer catheter 12 and guide catheter 14,respectively, enable axial advancement and rotational motion of guidecatheter 14 through the lumen of outer catheter 12 until engager 54 ofcatheter 14 is aligned with and engages slit 52 of catheter 12, as willbe described hereinbelow. As shown in cross-section A-A of FIG. 1, guidecatheter 14 is configured to be concentrically disposed within a lumenof outer catheter 12. It is to be noted that the scope of the presentinvention includes catheter 12 providing the shorter coupling, andcatheter 14 providing the longer coupling. For example, catheter 14 maybe shaped so as to provide slit 52, and catheter 12 may comprise engager54, which is configured to engage slit 52 of catheter 14.

As shown in the exploded view of view B, first coupling 152 is shaped todefine slit 52. For some applications, slit 52 is provided by a metalframe 50, as shown. Metal frame 50 has a length L22 of between 7 and 15mm, e.g., 13 mm. For such applications, a slit is created in material ofcatheter 12 (e.g., by creating a slit in the polymer material ofcatheter 12 during manufacturing of catheter 12), and frame 50 iscoupled to catheter 12. Second coupling 154 comprises an engager 54which comprises a protrusion disposed at a distal portion ofdisplaceable tab 56 of a base of engager 54. The base of engager 54 isshaped to define slits 57 which form tab 56. Engager 54 is depressiblewhen a force is applied thereto, and tab 56 facilitates movement ofengager 54 in response to and in the absence of force applied to engager54. For some applications, during manufacture of catheter 14, catheter14 is manipulated in order to couple thereto engager 54 and tabs 56,e.g., engager 54 and tabs 56 are embedded within the polymer of catheter14.

It is to be noted that although slit 52 and depressible engager 54 areshown on outer catheter 12 and guide catheter 14, respectively, atdistal portions of catheters 12 and 14, slit 52 and engager 54 may beprovided along any suitable portion of catheters 12 and 14, respectively(e.g., respective proximal portions of catheters 12 and 14).

FIG. 2 shows the concentric relationship between components of tubularsystem 10 (in an exploded view on the left side of FIG. 2). As describedhereinabove, a distal end portion of outer catheter 12 is steerable. Thedistal end portion of outer catheter 12 comprises a pull ring 11 that iscoupled to two or more pull wires 29 a and 29 b, that are disposedwithin respective secondary lumens within a wall of catheter 12 (asshown in section A-A). As shown in the exploded view, guide catheter 14is configured to be concentrically disposed within the lumen of catheter12. As described hereinabove, the distal end portion of guide catheter14 is steerable. The distal end portion of catheter 14 comprises a pullring 13 that is coupled to two or more pull wires 31 a and 31 b, thatare disposed within respective secondary lumens within a wall ofcatheter 14 (as shown in sections A-A and B-B).

Guide catheter 14 is steerable to a desired spatial orientation in orderto facilitate advancing and implantation of an implant in a body cavityof the patient. As shown, the implant comprises an annuloplasty ringstructure 222 comprising a flexible sleeve 26 (shown in the explodedview of FIG. 2). Sleeve 26 typically comprises a braided fabric mesh,e.g., comprising DACRON™. Sleeve 26 is typically configured to be placedonly partially around a cardiac valve annulus (i.e., to assume aC-shape), and, once anchored in place, to be contracted so as tocircumferentially tighten the valve annulus. Alternatively, the ringstructure is configured to be placed entirely around the valve annulus.In order to tighten the annulus, annuloplasty ring structure 222comprises a flexible elongated contracting member 226 that extends alongsleeve 26. Elongated contracting member 226 comprises a wire, a ribbon,a rope, or a band, which typically comprises a flexible and/orsuperelastic material, e.g., nitinol, polyester, stainless steel, orcobalt chrome. For some applications, the wire comprises a radiopaquematerial. For some applications, contracting member 226 comprises abraided polyester suture (e.g., Ticron). For some applications,contracting member 226 is coated with polytetrafluoroethylene (PTFE).For some applications, contracting member 226 comprises a plurality ofwires that are intertwined to form a rope structure.

For applications in which system 10 is used to deliver an implant to themitral valve of the patient, typically, outer catheter 12 is configuredfor initial advancement through vasculature of the patient until adistal end 102 of catheter 12 is positioned in the left atrium. Thedistal steerable end portion of catheter 12 is then steered such thatdistal end 102 of catheter 12 is positioned in a desired spatialorientation within the left atrium. The steering procedure is typicallyperformed with the aid of imaging, such as fluoroscopy, transesophagealecho, and/or echocardiography. Following the steering of the distal endportion of catheter 12, guide catheter 14 (which houses annuloplastyring structure 222) is advanced through catheter 12 in order tofacilitate delivery and implantation of structure 222 along the annulusof the mitral valve. During the delivery, at least a portion of thesteerable distal end portion of catheter 14 is exposed from distal end102 of catheter 12 and is thus free for steering toward the annulus ofthe mitral valve, as is described hereinbelow.

Annuloplasty ring structure 222 further comprises an adjusting mechanism40, which facilitates contracting and expanding of annuloplasty ringstructure 222 so as to facilitate adjusting of a perimeter of theannulus and leaflets of the cardiac valve. Adjusting mechanism 40 isdescribed in more detail hereinbelow. Adjusting mechanism 40 comprises arotatable structure (e.g., a spool, as described hereinbelow) that isdisposed within a housing 44. As shown in the enlarged image of FIG. 1,adjusting mechanism 40 is surrounded by a braided mesh and is coupled(e.g., by being sutured or otherwise coupled) to the braided mesh ofsleeve 26. For some applications, adjusting mechanism 40 is coupled toan outer, lateral surface of sleeve 26. During delivery of sleeve 26 tothe annulus of the cardiac valve, sleeve 26 is disposed within a lumenof catheter 14 and sleeve 26 and mechanism 40 are aligned longitudinallywith a longitudinal lumen of catheter 14. Such coupling of mechanism 40to sleeve 26 allows mechanism 40 to transition from a state in which itis in line with the longitudinal axis of catheter 14 (FIG. 2) to a statein which it is disposed alongside sleeve 26 (FIG. 1). The positioning ofadjusting mechanism 40 alongside a portion of sleeve 26 exposes adriving interface of the rotational structure to be accessed by arotational tool that is guided toward adjusting mechanism 40 via guidemember 86.

A flexible, longitudinal guide member 86 (e.g., a wire) is coupled to aportion of adjusting mechanism 40 (e.g., a portion of the rotatablestructure, as described hereinbelow). Guide member 86 is configured tofacilitate guiding of a rotational tool via guide member 86 and towardthe rotatable structure of adjusting mechanism 40. Typically, therotational tool is configured to engage the rotatable structure ofadjusting mechanism 40 following implantation of sleeve 26 along theannulus of the cardiac valve. Guide member 86 passes from adjustingmechanism 40, alongside a portion of the distal end portion of guidecatheter 14, and into a secondary lumen in the wall of guide catheter14, through an opening 15 in guide catheter 14. Guide member 86 passesthrough the secondary lumen of guide catheter 14 (as shown in sectionsA-A and B-B in FIG. 2) and has a proximal end that is accessible fromoutside the body of the patient. The secondary lumen in the wall ofguide catheter 14 facilitates passage of guide member 86 through system10 without interfering with the other concentrically-disposed elongatetubular members that pass concentrically through the lumen of guidecatheter 14.

In addition, system 10 comprises a plurality of anchors 32, typicallybetween about 5 and about 20 anchors, such as about 10 or about 16anchors. Each anchor 32 comprises a tissue coupling element 60 (e.g., ahelical tissue coupling element), and a tool-engaging head 62, fixed toone end of the tissue coupling element. Only one anchor 32 is shown inFIG. 2 as being reversibly coupled to a deployment element 38 of arotating anchor driver 36 of an anchor deployment manipulator 61. Whensleeve 26 is disposed along the annulus of the cardiac valve, deploymentmanipulator 61 is configured to advance within a lumen of sleeve 26 anddeploy each anchor 32 from within sleeve 26 through a wall of sleeve 26and into cardiac tissue, thereby anchoring sleeve 26 around a portion ofthe valve annulus. The insertion of the anchors into the sleeve anddeployment of the anchors into cardiac tissue is described in detailhereinbelow.

Typically, but not necessarily, anchors 32 comprise a biocompatiblematerial such as stainless steel 316 LVM. For some applications, anchors32 comprise nitinol. For some applications, anchors 32 are coated with anon-conductive material.

Deployment manipulator 61 comprises anchor driver 36 and deploymentelement 38.

As shown in the exploded view of FIG. 2, sleeve 26 is disposed within alumen of guide catheter 14. A force is applied to a proximal end ofsleeve 26 is by a distal end of a reference-force tube 19. As shown, animplant-decoupling channel 18 is advanceable within a lumen ofreference-force tube 19 and through a lumen of sleeve 26. Typically,decoupling channel 18 fits snugly within sleeve 26. As shown in theenlarged image of FIG. 1, a distal end 17 of implant-decoupling channel18 is disposed in contact with an inner wall of sleeve 26 at a distalend thereof. Additionally, a distal end portion of channel 18 comprisesa radiopaque marker 1018. As shown, tube 19 and sleeve 26 arelongitudinally and coaxially disposed with respect to each other.

Typically, manipulator 61 advances within channel 18. For someapplications, system 10 comprises a plurality of anchor drivers 36 ofmanipulator 61, each driver 36 being coupled to a respective anchor 32.Each driver 36 is advanced within channel 18 in order to advance andimplant anchor 32 in tissue. Following implantation of anchor 32, anchor32 is decoupled from driver 36, as described herein, and driver 36 isremoved from within channel 18. Subsequently, a new driver 36 coupled toanother anchor 32 is then advanced within channel 18.

As will be described hereinbelow, a first anchor 32 is configured to bedeployed through the wall of the sleeve into cardiac tissue, when sleeve26 is positioned along the annulus of the valve. Following thedeployment of the first anchor, a distal portion of sleeve 26 is sliddistally off a portion of implant-decoupling channel 18. In order todecouple sleeve 26 distally from a portion of outer surface of channel18, (1) a proximal force is applied to channel 18, while (2)reference-force tube 19 is maintained in place in a manner in which adistal end of tube 19 provides a reference force to sleeve 26 in orderto facilitate freeing of a successive portion of sleeve 26 from aroundchannel 18. Channel 18 is then positioned at a successive locationwithin the lumen of sleeve 26 while either tube 19 and/or catheter 14 issteered toward a successive location along the annulus of the valve (aswill be described hereinbelow). Consequently, the successive portion ofsleeve 26 provides a free lumen for advancement of a successive anchor32 and deployment of the anchor through the wall of the sleeve at thesuccessive portion thereof. Such freeing of the successive portion ofsleeve 26 creates a distance between successive anchors deployed fromwithin the lumen of sleeve 26.

For some applications, sleeve 26 comprises a plurality of radiopaquemarkers 25, which are positioned along the sleeve at respectivelongitudinal sites. The markers may provide an indication in aradiographic image (such as a fluoroscopy image) of how much of thesleeve has been deployed at any given point during an implantationprocedure, in order to enable setting a desired distance between anchors32 along the sleeve. For some applications, the markers comprise aradiopaque ink.

Typically, at least a portion (e.g., at least three, such as all) of thelongitudinal sites are longitudinally spaced at a constant interval.Typically, the longitudinal distance between the distal edges ofadjacent markers, and/or the distance between the proximal edges ofadjacent markers, is set equal to the desired distance between adjacentanchors. For example, the markers may comprise first, second, and thirdmarkers, which first and second markers are adjacent, and which secondand third markers are adjacent, and the distance between the proximaland/or distal edges of the first and second markers equal thecorresponding distance between the proximal and/or distal edges of thesecond and third markers. For example, the distance may be between 3 and15 mm, such as 6 mm, and the longitudinal length of each marker may bebetween 0.1 and 14 mm, such as 2 mm. (If, for example, the distance were6 mm and the length were 2 mm, the longitudinal gaps between adjacentmarkers would have lengths of 4 mm.)

Each anchor 32 is coupled to deployment element 38 of anchor driver 36.Anchor driver 36 comprises an elongate tube having at least a flexibledistal end portion. The elongate tube of driver 36 extends within alumen of channel 18, through system 10 toward a proximal end of aproximal handle portion 101 of system 10. Typically, the lumen ofchannel 18 has a transverse cross-sectional diameter of at least 2 mm,such as at least 2.5 mm. The tube of anchor driver 36 provides a lumenfor slidable advancement therethrough of an elongate rod 130. Rod 130facilitates the locking and unlocking of anchor 32 to deployment element38, as is described hereinbelow. As shown in Section E-E of FIG. 2, aproximal end of rod 130 is coupled to a component of an anchor-releasemechanism 28 at a proximal end of system 10. Mechanism 28 comprises ahousing 135 and a finger-engager 131 that is coupled to the proximal endof rod 130. Finger-engager 131 is coupled to a housing 135 via a spring133 (section E-E of FIG. 2). A proximal end of the tube of anchor driver36 is coupled to housing 135. As is described hereinbelow, the physicianreleases anchor 32 from deployment element 38 when finger-engager 131 ispulled proximally, thereby pulling rod 130 proximally.

Proximal handle portion 101 is supported by a stand having support legs91 and a handle-sliding track 90. Handle portion 101 comprises anouter-catheter handle 22, a guide-catheter handle 24, animplant-manipulating handle 126, and anchor-release mechanism 28. Handle22 is coupled to a proximal end of outer catheter 12. Handle 24 iscoupled to a proximal portion of guide catheter 14. Handle 126 iscoupled to a proximal portion of reference-force tube 19. As describedhereinabove, housing 135 of anchor-release mechanism 28 is coupled to aproximal portion of the tube of anchor driver 36. The relativepositioning of each of the concentrically-disposed components of system10 is shown in the exploded view and sections A-A, B-B, C-C, and D-D ofFIG. 2.

The stand supporting proximal handle portion 101 may be moved distallyand proximally to control a position of the entire multi-componentsystem 10, particularly so as to adjust a distance of distal end 102 ofcatheter 12 from the interatrial septum. Handle 22 comprises a steeringknob 210 that is coupled to steering wires 29 a and 29 b disposed withinrespective secondary lumens in the wall of outer catheter 12. Rotationof knob 210 adjusts a degree of tension of wires 29 a and 29 b which, inturn, apply a force to pull ring 11 at the distal end portion of outercatheter 12. Such force steers the distal end portion of catheter 12within the atrium of the heart of the patient in a manner in which thedistal end portion of catheter 12 is steered in a first plane that istypically parallel with the plane of the annulus of the valve (e.g., ina direction from the interatrial septum toward surrounding walls of theatrium). For some applications of the present invention, the distal endportion of catheter 12 may be pre-shaped so as to point downward towardthe valve. For other applications, the distal end portion of catheter 12may be pulled to assume an orientation in which the distal end portionpoints downward toward the valve. For yet other applications of thepresent invention, the distal end portion of catheter 12 is not made topoint downward toward the valve.

Handle 24 is coupled to track 90 via a first mount 92. Mount 92 isslidable proximally and distally along track 90 in order to control anaxial position of guide catheter 14 with respect to outer catheter 12.Mount 92 is slidable via a control knob 216. For example, control knob216 of mount 92 controls the proximal and distal axial movement of thedistal steerable portion of guide catheter 14 with respect to distal end102 of outer catheter 12. Handle 24 comprises a steering knob 214 thatis coupled to steering wires 31 a and 31 b disposed within respectivesecondary lumens in the wall of guide catheter 14. Rotation of knob 214adjusts a degree of tension of wires 31 a and 31 b which, in turn, applya force to pull ring 13 at the distal end portion of guide catheter 14.Such force steers the distal end portion of catheter 14 in a secondplane within the atrium of the heart of the patient, typically downwardand toward the annulus of the cardiac valve. Typically, as describedhereinbelow, the second plane in which the distal end portion ofcatheter 14 is steered is substantially perpendicular to the first planein which the distal end portion of outer catheter 12 is steered.

The combined steering of the respective distal end portions of catheters12 and 14 directs sleeve 26 down toward the annulus (e.g., via thesteering of the distal end portion of catheter 14) and along theperimeter of the annulus (e.g., from the posterior section of the valveto the anterior section of the valve, and vice versa, e.g., via thesteering of the distal end portion of catheter 12).

For some applications, handle 22 may be tilted by the operatingphysician, in order to further adjust a position of the distal end ofcatheter 12.

As described herein, first and second couplings 152 and 154 of outercatheter 12 and guide catheter 14, respectively (e.g., slit 52 andengager 54, respectively), provide a controlled steerable system inwhich, during the steering and bending of the distal end portion ofguide catheter 14, the distal end portion of outer catheter 12 ismaintained in its steered configuration, or in its spatial orientation,without substantially affecting the steering or the bending of thedistal end portion of guide catheter 14. Thus, first and secondcouplings 152 and 154, respectively, minimize the effect of the distalend portion of outer catheter 12 on the steering and bending of catheter14. That is, first and second couplings 152 and 154 of outer catheter 12and guide catheter 14, respectively, collectively define arelative-spatial-orientation-controlling device which rotationally locksthe relative spatial orientation of the steerable distal end portion andthe bending section of outer catheter 12 with respect to the steerabledistal end portion and the bending section of guide catheter 14.

Guide member 86 exits from the lumen in the wall of guide catheter 14 ata portion of handle portion 101 that is between handles 22 and 24.

Handle 126 is coupled to track 90 via a second mount 93. Mount 93 isslidable proximally and distally along track 90, in order to control anaxial position of reference-force tube 19 and at least a proximalportion of sleeve 26 with respect to guide catheter 14. Mount 93 isslidable via a control knob 95. For example, control knob 95 of mount 93controls the proximal and distal axial movement of the tube 19 and atleast the proximal portion of sleeve 26 with respect to distal end 104of guide catheter 14. Taken together with the steering of the distal endportion of guide catheter 14, such movement of tube 19 and at least theproximal portion sleeve 26 moves the proximal portion of sleeve 26toward a desired portion of tissue of the annulus of the valve duringdeployment of anchors 32 from within the lumen of sleeve 26, as isdescribed hereinbelow.

As is described hereinabove, in order to decouple sleeve 26 from aportion of an outer surface of channel 18, (1) channel 18 is pulledproximally, while (2) reference-force tube 19 is maintained in place. Aproximal end of channel 18 is coupled to a knob 94 which adjusts anaxial position of channel 18 proximally and distally with respect toreference-force tube 19 and sleeve 26.

Handle portion 101 (comprising handles 22, 24, and 126 andanchor-release mechanism 28) has a length L1 of between 65 and 85 cm,e.g., 76 cm. Typically, as shown, a majority of the body portion ofouter-catheter handle 22 is disposed at a non-zero angle with respect toa longitudinal axis 7 of the multiple components of system 10. Thesteering mechanism provided by handle 22 in order to steer the distalend portion of catheter 12 is disposed within the portion of handle 22that is disposed at the non-zero angle with respect to axis 7. Handle 22comprises an in-line tubular portion 21 which is longitudinally disposedin-line along axis 7 and coaxially with respect to handles 24 and 126and release mechanism 28. Tubular portion 21 is shaped to define a lumenfor inserting guide catheter 14 therethrough and subsequently into thelumen of outer catheter 12 (as is described hereinbelow with referenceto FIG. 3A). Tubular portion 21 has a length L24 of between 7 and 11 cm,e.g., 7 cm. Such spatial orientation of the majority of handle 22 at anangle with respect to axis 7 reduces an overall functional length ofhandle portion 101.

Reference is now made to FIGS. 3A-E, which are schematic illustrationsof the functional relationship between first and second couplings 152and 154, respectively, and respective degrees of rotational freedom ofguide catheter 14 with respect to outer catheter 12, in accordance withsome applications of the present invention. It is to be noted that FIGS.3A-E show a functional relationship between catheters 12 and 14, and,for clarity of illustration, does not show the concentric componentsdisposed within a longitudinal lumen 59 of catheter 14 (i.e.,reference-force tube 19, channel 18, anchor driver 36, and rod 130, asshown in FIGS. 1 and 2). FIG. 3A shows catheters 12 and 14 in a stateprior to advancing catheter 14 through a lumen 58 of catheter 12.Sections A-A and B-B of FIG. 3A show slit 52, or first coupling 152,empty. Section C-C shows a portion of catheter 14 which provides engager54, or second coupling 154. As described hereinabove with reference toFIG. 1, engager 54 is coupled to a depressible tab 56 which facilitatesdepressible movement of engager 54 when a force is applied thereto(e.g., at a later stage by an inner wall 51 of catheter 12 thatsurrounds lumen 58 when catheter 14 is advanced through lumen 58, as isdescribed hereinbelow). As shown in section C-C of FIG. 3A, in theabsence of a pushing force, tab 56 is disposed in parallel withlongitudinal axis 7, and engager 54 is in a resting state thereof inwhich engager 54 is not in a depressed state and protrudes from anexternal surface of catheter 14.

As shown in sections A-A and B-B of FIGS. 3A-B, first coupling 152 isprovided in a manner in which lumen 58 of catheter 12 is free from anyprotrusions. Additionally, inner wall 51 of catheter 12 is not shaped todefine any interrupted portions, such as recessed portions, along aproximal portion of catheter 12 and extending toward distal end 102 ofcatheter 12, except for slit 52 at a distal portion thereof. Oncecatheter 12 is advanced through the vasculature of the patient, distalend 104 of catheter 14 is configured to enter a lumen provided bytubular portion 21 of handle 22, and subsequently, catheter 14 passesthrough lumen 58 of catheter 12. View E is a view of lumen 58 ofcatheter 12 from a proximal portion of tubular portion 21 of handle 22.Since lumen 58 is free from any protrusions or recessed portions, asdescribed hereinabove, and since engager 54 is depressible by tab 56,catheter 14 is configured to enter lumen 58 of catheter 12 in anyrotational configuration thereof. Catheter 14 is shown in section D-D ina manner in which engager is oriented at 12 o'clock, by way ofillustration and not limitation. Catheter 14 may enter lumen 58 ofcatheter 12 in any rotational configuration thereof, therefore engager54 is shown in phantom in a plurality of orientations in section D-D,since catheter 14 may enter lumen 58 of catheter 12 in a rotationalorientation in which engager 54 may be oriented in any given orientationwith respect to inner wall 51 of catheter 12. Similarly, until couplings152 and 154 are engaged (i.e., coupled to each other), catheter 14 maybe freely rotated within catheter 12.

During the insertion of distal end 104 and the distal portion ofcatheter 14, the physician pushes down on engager 54 such that engager54 fits within the lumen of catheter 12. In response to the pushingforce on engager 54, tab 56 is pushed downward as well.

Typically, catheter 12 has an inner diameter (or the diameter of lumen58) of between 6.5 and 7.0 mm (e.g., 6.85 mm). Typically, catheter 14has an inner diameter (or the diameter of lumen 59) of between 4.7 and5.3 mm (e.g., 5.1 mm). System 10, by providing slit 52 and depressibleengager 54, provides a system in which the inner diameters of catheters12 and 14 are maintained during given stages of the procedure. Forexample, engager 54 maintains the inner diameter of catheter 12 ascatheter 14 is advanced within the lumen of catheter 12, and slit 52maintains the inner diameter of catheter 14 once engager 54 pops up andis disposed within slit 52. That is, once catheters 12 and 14 arecoupled via the engager and slit, the lumen of catheter 14 is typicallyconstant along the length of the catheter (e.g., there are noprotrusions into catheter 14), thereby facilitating sliding through thelumen of large elements.

FIG. 3B shows the axial advancement of a distal portion of catheter 14through the lumen of catheter 12 in the direction as indicated by arrow1. Typically, the advancement of catheter 14 through catheter 12 iscontrolled by the physician who moves handle 24 axially closer to handle22. During the advancement of catheter 14 through catheter 12, engager54 is maintained in a pushed state (as shown in section A-A of FIG. 3B)by a pushing force applied thereto by inner wall 51 of catheter 12. Asshown in section B-B of FIG. 3B, inner wall 51 of outer catheter 12pushes on engager 54, in the direction as indicated by the radial arrow.In response to the force applied on engager 54 by inner wall 51 ofcatheter 12, engager 54 is pushed and tab 56 is displaced at a non-zeroangle with respect to axis 7 in order to allow for depression of engager54. During the depression of engager 54, engager 54 is pushed slightlywithin lumen 59 of catheter 14.

As described hereinabove, inner wall 51 of catheter 12 is smooth anduninterrupted by recesses or slits (except for slit 52 at the distal endof catheter 12). First coupling 152 (e.g., slit 52 thereof) is disposedat a given longitudinal site of catheter 12, and slit 52 typically has alength L2 (shown in view B of FIG. 1) of between 5 and 15 mm, e.g., 10mm. A proximal-most end of slit 52 is disposed up to 100 mm (e.g., up to60 mm) from distal end 102 of catheter 12. Catheter 12 is typicallybetween 80 and 100 cm long. Thus, inner wall 51 of the proximal portionof catheter 12, until the proximal-most end of slit 52, is smooth anduninterrupted by recesses or slits. Taken together, the depressibilityof engager 54 and such a smooth configuration of inner wall 51 ofcatheter 12 enables rotation of catheter 14 by 360 degrees (i.e., asindicated by arrow 2) within the lumen of catheter 12.

For some applications, it is hypothesized that the relatively shortlengths of couplings 152 and 154 relative to the lengths of catheters 12and 14, and the absence of interruptions such as lateral openings (e.g.,slits) and/or protrusions, other than those of the couplings,facilitates the use of catheters with lateral walls that are thinnerthan those of a catheter that, for example, comprises a coupling thathas a longer relative length.

FIG. 3C shows further axial advancement of catheter 14 within the lumenof catheter 12. As described hereinabove, during the advancement, andprior to the engaging of engager 54 with slit 52 (as is describedhereinbelow with reference to FIG. 3D), inner wall 51 pushes on engager54 such that catheter 14 can be rotated to any suitable rotationalorientation within outer catheter 12. For example, engager 54 is shownat 2 o'clock in section B-B of FIG. 3B, while engager 54 is shown at 11o'clock in section B-B of FIG. 3C. That is, while second coupling 154(e.g., engager 54 thereof) is disposed proximal to the longitudinal siteat which first coupling 152 (e.g., slit 52 thereof) is disposed,catheter 14 is rotatable within the lumen of catheter 12. Furthermore,prior to the engaging of engager 54 with slit 52 catheter 14 may beextracted from within the lumen of catheter 12.

FIG. 3C shows axial advancement of catheter 14 within catheter 12 in thedistal direction, as indicated by arrow 1, in a manner in which engager54 is about to engage with slit 52 at a distal portion of catheter 12.FIG. 3C shows a relative position of catheter 14 with respect tocatheter 12 in a manner in which catheter 14 is not fully pushed withincatheter 12. Handle 24 of catheter 14 is still distanced from handle 22of catheter 12. However, catheter 14 is pushed distally sufficiently fordistal end 104 and a portion of the distal end portion of catheter 14 toemerge from within catheter 12 and extend distally beyond distal end 102of catheter 12.

Following further distal advancement of catheter 14 within catheter 12,and slight rotation of catheter 14 within the lumen of catheter 12,engager 54 of catheter 14 is aligned with slit 52 of catheter 12, asshown in FIG. 3D. In the absence of the pushing force of inner wall 51of catheter 12 on engager 54, engager 54 returns to its resting stateand protrudes within slit 52 so as to engage slit 52. That is, firstcoupling 152 is engaged with (i.e., coupled to) second coupling 154. Asengager 54 returns to its resting state, tab 56 returns to a position inwhich it is parallel with respect to longitudinal axis 7. That is, in agiven orientation of catheter 14, when second coupling 154 (e.g.,engager 54 thereof) becomes disposed at the longitudinal site at whichfirst coupling 152 (e.g., slit 52 thereof) is disposed, the secondcoupling automatically couples to the first coupling.

FIG. 3D shows engager 54 in a distal-most position within slit 52, i.e.,a fully-pushed state of catheter 14. As such, handles 24 and 22 aredisposed adjacently to each other. In this state, an exposed distal endportion 114 of catheter 14 extends beyond distal end 102 of catheter 12.Typically, at least a portion of distal end portion 114 is steerable andbendable, as is described hereinbelow. Distal end portion 114 ofcatheter 14 has a length L3 of between 25 and 35 mm, e.g., 30 mm. Asdescribed hereinabove, slit 52 has a length L2 of between 5 and 15 mm,e.g., 10 mm.

Reference is now made to FIGS. 1 and 3D. As shown in view B of FIG. 1,engager 54 has a longitudinal length L26 of between 2 and 3 mm, e.g., 2mm. Length L26 facilitates motion of engager 54 along length L2 of slit52. A proximal-most end of engager 54 is disposed up to 120 mm (e.g., upto 80 mm) from distal end 104 of catheter 14. As described hereinabove,a proximal-most end of slit 52 is disposed up to 100 mm (e.g., up to 60mm) from distal end 102 of catheter 12. Thus, since slit 52 has a lengthL2 of between 5 and 15 mm, e.g., 10 mm, when engager 54 is disposed at adistal-most position within slit 52, as shown in FIG. 3D, exposed distalend portion 114 of catheter 14 has a length L3 of between 20 and 35 mm,e.g., 30 mm.

For some applications, the combined lengths of first and secondcouplings 152 and 154, respectively, is less than 30 mm, e.g., less than20 mm. For applications in which first coupling 152 (e.g., slit 52) isbetween 5 and 15 mm, and second coupling 154 (e.g., engager 54) isbetween 2 and 3 mm, the combined lengths of first and second couplings152 and 154, respectively, is less than 50 mm, e.g., less than 20 mm.

Engager 54 has a longitudinal lengthL26 that is less than 30% (e.g.,less than 20%) of the longitudinal length of catheter 14. Typically,however, as described hereinabove, engager 54 has a length L26 ofbetween 2 and 3 mm. That is, engager 54 has a longitudinal length thatis less than 2% (e.g., less than 1%) of the longitudinal length ofcatheter 14.

Reference is now made to FIGS. 3C-D. A portion of exposed distal endportion 114 extends beyond distal end 102 of catheter 12 prior toengager 54 engaging slit 52. The length L2 of slit 52 enables retractionof catheter 14 between 5 and 15 mm, proximally from the fully-pushedstate of catheter 14. As catheter 14 is retracted proximally, engager 54moves proximally within slit 52 until a proximal-most end of engager 54contacts a proximal-most end of slit 52. When engager 54 is disposed atthe proximal-most end of slit 52, the distal end portion exposed fromwithin catheter 44412 is between 10 and 30 mm, e.g., 20 mm. Whencatheter 14 is pushed distally, engager 54 moves distally within slit 52until a distal-most end of engager 54 contacts a distal-most end of slit52.

Reference is again made to FIG. 3D. In the state in which engager 54 isdisposed within slit 52, catheter 14 is restricted from rotating withinthe lumen of catheter 12, and catheters 12 and 14 are therebyrotationally locked with respect to each other.

FIG. 3E shows catheter 12 and 14 in a state in which catheter 14 hasbeen pushed fully within catheter 12 (i.e., a state in which engager 54is disposed at a distal-most end of slit 52 and handle 24 is disposedadjacently to handle 22). As described hereinabove, during thefully-pushed state of catheter 14, exposed distal portion 114 extendsbeyond distal end 102 of catheter 12 and has a length L3 of between 25and 35 mm, e.g., 30 mm. Additionally, as is described herein, at least aportion of distal end portion 114 is steerable and comprises an exposedbending section 1403 which is a portion of a collective distal bendingsection 1405 of catheter 14 (described hereinbelow with reference toFIGS. 5 and 6). A distal end portion of catheter 12 comprises a bendingsection 1203 (described hereinbelow with reference to FIGS. 4 and 6). Aproximal portion of bending section 1405 of catheter 14 is bendable anddisposed within the lumen of catheter 12 at bending section 1203thereof.

The distal end portion of catheter 12 is steerable in a first plane(e.g., a plane that is parallel with respect to the cardiac valve of thepatient). Bending section 1403 of exposed distal portion 114 (andadditional portions of collective bending section 1405) is steerable insecond plane that is substantially perpendicular to the first plane inwhich the distal end portion of catheter 12 is steerable (e.g., a planethat is perpendicular with respect to the valve of the patient).Typically, this configuration is achieved by couplings 152 and 154locking the catheters such that a plane on which pull wires 29 a and 29b lie is generally orthogonal to a plane on which pull wires 31 a and 31b lie. As shown, bending section 1203 of the steerable distal endportion of outer catheter 12 is maintained in its steered configuration,or in its spatial orientation, without substantially affecting thesteering of exposed distal end portion 114 of guide catheter 14, nor ofthe bending of bending section 1403, nor of the collective bendingsection 1405 (including the proximal portion of bending section 1405 ofcatheter 14 that is disposed within the lumen of catheter 12 at bendingsection 1203 thereof). That is, first and second couplings 152 and 154,respectively, advantageously reduce the effect of the distal end portionof catheter 12 on the steering of section 114 and the bending of bendingsection 1405. That is, first and second couplings 152 and 154 of outercatheter 12 and guide catheter 14, respectively, collectively define arelative-spatial-orientation-controlling device which rotationally locksthe relative spatial orientation of the steerable distal end portion andbending section 1203 of outer catheter 12 with respect to the steerabledistal end portion and bending section 1405 of guide catheter 14,specifically of exposed bending section 1403.

Thus, for applications in which system 10 is used to treat the mitralvalve, bending section 1203 of catheter 12 bends the steerable distalend portion of catheter 12 within the atrium in the first plane that isparallel with respect to the mitral valve. First and second couplings152 and 154, respectively, enable (1) bending of bending section 1405toward the valve in the second plane that is substantially perpendicularwith respect to the first plane and to the plane of the mitral valve,while (2) restricting or minimizing the effect of the spatialorientation of bending section 1203 of catheter 12 on bending section1405 of catheter 14.

Reference is now made to FIGS. 3A-E. It is to be noted that for someapplications, slit 52 has a longitudinal length L2 of less than 20 cm,e.g., a length of less than 15 cm. That is, slit 52 has a longitudinallength L2 that is less than 30% (e.g., less than 20%) of thelongitudinal length of catheter 12. Typically, however, as describedhereinabove, slit 52 has a length L2 of between 5 and 15 mm, e.g., 10mm. That is, slit 52 has a longitudinal length that is less than 2%(e.g., less than 1%) of the longitudinal length of catheter 12. For suchapplications, the proximal-most end of slit 52 is disposed up to 30 mmfrom distal end 102 of catheter 12.

It is to be noted that the scope of the present invention includesproviding slit 52 and engager 54 at respective proximal portions ofcatheters 12 and 14, respectively. For such applications, a distal-mostend of slit 52 is disposed up to 100 mm (e.g., up to 60 mm) from theproximal end of catheter 12 and a distal-most end of engager 54 isdisposed up to 120 mm (e.g., up to 80 mm) from the proximal end ofcatheter 14.

Reference is now made to FIGS. 1, 2, and 3A-E. It is to be noted thatfirst and second couplings 152 and 154, respectively, may be provided onany standard catheter. That is, coupling 152 comprises frame 50 whichcan be coupled to an external surface of any standard catheter (in whichcase, a corresponding slit would be made in the standard catheter).Additionally coupling 154 may be coupled to any standard catheter bycoupling the base portion of coupling 154 to any standard catheter.Suitable adjustments to the standard catheter would be made toaccommodate the displacing of tab 56 and engager 54 in response topushing forces applied to engager 54.

Reference is now made to FIG. 4, which is a schematic illustration ofcatheter 12 comprising a multiple-durometer section 1210 at a distalsteerable end portion of catheter 12, in accordance with someapplications of the present invention. Multiple-durometer section 1210has a length L18 of between 30 mm and 40 mm, e.g., 36 mm. Each sectionof multiple-durometer section 1210 has a respective durometer sectionsin Shore D, or scale D. Catheter 12 comprises a uniform durometersection 1205 that is disposed proximal to multiple-durometer bendingsection 1210. Typically, multiple durometer section 1210 and uniformdurometer section 1205 comprise an elastic tubular polymer 1206 (e.g.,sequences of polyamide 12 segments (PA12) and polytetramethylene glycolsegments (PTMG), polyether block amide, or PEBA) that defines thetubular structure of catheter 12. Polymer 1206 has mechanical anddynamic properties which impart flexibility, impact resistance, energyreturn, and fatigue resistance to catheter 12.

As shown in the cross-sectional image, catheter 12 provides a wall whichdefines lumen 58. The inner wall of catheter 12 (which defines lumen 58)is coated with a friction-reducing liner comprisingpolytetrafluoroethylene (PTFE) so as to reduce friction during thesliding of catheter 14 through lumen 58 of catheter 12. The wall ofcatheter 12 is shaped to define secondary lumens 1211, which aretypically spaced apart from each other by 180 degrees. A respective pullwire 29 a and 29 b (not shown in FIG. 4 for clarity of illustration, butare shown in FIGS. 1 and 2) is advanced through each lumen 1211. Theinner walls of each secondary lumen 1211 is coated with afriction-reducing liner comprising polytetrafluoroethylene (PTFE) so asto reduce friction during the sliding of respective wires 29 a and 29 btherethrough.

Typically, catheter 12 has an inner diameter D1 (or the diameter oflumen 58) of more than 6.5 mm and/or less than 7.0 mm (e.g., 6.85 mm)and an outer diameter D2 of more than 7.0 mm and/or less than 9.0 mm(e.g., 8.3 mm).

It is to be noted that even though catheter 12 has multiple durometersegments, inner and outer diameters D1 and D2, respectively, remainconstant along a longitudinal length L8 of catheter 12 (with theexception of outer diameter D2 being tapered at the distal end portionof section 1201, as is described hereinbelow).

Typically, catheter 12 has a longitudinal length L8 of between 700 and1200 mm, e.g., between 800 and 900 mm, e.g., between 853 and 867 mm,e.g., 860 mm. Uniform durometer section 1205 has a length L9 that isbetween 770 and 860 mm, e.g., 824 mm. Tubular polymer 1206 extends anentire length L8 of catheter 12. Catheter 12 is surrounded by a braidedmesh 1207, which typically comprises a flexible metal (e.g., stainlesssteel 304 or nitinol). Typically, braided mesh 1207 extends along thelength of catheter 12 until a proximal portion at which the pull wires29 a and 29 b (not shown for clarity of illustration) are exposed fromwithin lumens 1211 at a proximal section of catheter 12, e.g., between823 and 837 mm (e.g., 830 mm) from distal end 102 of catheter 12.

Section 1210 comprises a distal pull-ring section 1201 in which pullring 11 is disposed. Typically, a distal-most portion of section 1201 istapered so as to facilitate atraumatic advancement of catheter 12through the vasculature of the patient. Section 1201 has a length ofbetween 4 and 5 mm (e.g., 4.5 mm) and has a durometer of between 45D and63D (e.g., 55D). Such a durometer of section 1201 imparts more hardnessand rigidity to the distal portion of catheter 12 in which pull ring 11is disposed, such that portion section 1201 supports ring 11 andprotects the distal portion of catheter 12 from the impact of forcesapplied thereto during the pulling of pull ring 11 by the pull wires.Typically, pull ring 11 has a length of between 2.5 and 2.6 mm, e.g.,2.54 mm. A distal transition section 1202 is disposed proximal tosection 1201 and has a length L5 of between 1 and 2 mm (e.g., 1.5 mm)and has a durometer of between 63D and 72D (e.g., 72D). The relativelyhigh durometer of section 1202 imparts hardness to section 1202 suchthat pull ring 11 is supported and maintained in place during thepulling of pull ring 11 by the pull wires. Thus, section 1202 helpsovercome high tensile forces acting on the distal end of catheter 12.

Catheter 12 provides bending section 1203 proximally adjacent to section1202. As shown in the enlarged image, bending section 1203 comprises acoil 1208 which is embedded within the tubular polymer 1206. Typically,coil 1208 comprises a flexible metal (e.g., stainless steel 304 ornitinol). Coil 1208 imparts efficient and durable bending (e.g.,flexibility) to bending section 1203. Additionally, polymer 1206 atbending section 1203 has a durometer of between 25D and 45D (e.g., 35D)which provides a degree of softness that facilitates bending of thedistal steerable portion of catheter 12 at bending section 1203. Bendingsection 1203 has a length L6 of between 22 and 27 mm, e.g., 25 mm.

Typically, bending section 1203 has a maximum bending angle between 120and 140 degrees (e.g., 127 degrees). That is, bending section 1203 canbend between 0 and 140 degrees. For some applications, bending section1203 has a pre-shaped angle of between 40 and 55 degrees (e.g., 45degrees) so as to reduce force applied to bending section 1203 ofcatheter 12 by pull wires 29 a and 29 b.

It is to be noted that only tubular polymer 1206 and braided mesh 1207extend proximally and distally beyond bending section 1203.

Proximally adjacent to bending section 1203 is a transition section 1204having a length L7 of between 4 and 6 mm (e.g., 5 mm). Proximallyadjacent to transition section 1203 is uniform durometer section 1205.Uniform durometer section 1205 has a durometer of between 63D and 72D(e.g., 72D). Transition section 1204 has a durometer of between 35D and55D (e.g., 45D) so as to provide a transition from the relatively lowdurometer of bending section 1203 to the relatively high durometer ofuniform durometer section 1205.

FIG. 4 shows the relative position of slit 52 with respect to distal end102 of catheter 12. As described hereinabove, a proximal-most end ofslit 52 is disposed up to 100 mm (e.g., up to 60 mm) from distal end 102of catheter 12.

Typically, the spatial orientation of bending section 1203 is determinedby pulling on pull wires 29 a and 29 b that are disposed within lumens1211 (wires 29 a and 29 b are not shown for clarity of illustration).Bending section 1203, for some alternative applications of the presentinvention, may be pre-shaped (e.g., at 45 degrees with respect to atransverse plane provided by opposing pull wires 29 a and 29 b) toassume a given spatial orientation and the spatial orientation ofsection 1203 is additionally determined by pulling on pull wires 29 aand 29 b.

Reference is now made to FIG. 5, which is a schematic illustration ofcatheter 14 comprising a multiple-durometer section 1410 at a distalsteerable end portion of catheter 14, in accordance with someapplications of the present invention. Multiple-durometer section 1410has a length L19 of between 70 mm and 80 mm, e.g., 74 mm. Each sectionof multiple-durometer section 1410 has a respective durometer sectionsin Shore D, or scale D. Catheter 14 comprises a uniform durometersection 1407 that is disposed proximal to multiple-durometer bendingsection 1410. Typically, multiple durometer section 1410 and uniformdurometer section 1407 comprise an elastic tubular polymer 1416 (e.g.,sequences of polyamide 12 segments (PA12) and polytetramethylene glycolsegments (PTMG), polyether block amide, or PEBA) that defines thetubular structure of catheter 14. Polymer 1416 has mechanical anddynamic properties which impart flexibility, impact resistance, energyreturn, and fatigue resistance to catheter 14.

As shown in the cross-sectional image, catheter 14 provides a wall whichdefines lumen 59. The inner wall of catheter 14 (which defines lumen 59)is coated with a friction-reducing liner comprisingpolytetrafluoroethylene (PTFE) so as to reduce friction during thesliding of tube 19 (not shown for clarity of illustration, but shown inFIGS. 1 and 2) through lumen 59 of catheter 14. The wall of catheter 14is shaped to define secondary lumens 1421, which are typically spacedapart from each other by 180 degrees. A respective pull wire 31 a and 31b (not shown in FIG. 5 for clarity of illustration, but are shown inFIGS. 1 and 2) is advanced through each lumen 1421. The inner walls ofeach secondary lumen 1421 is coated with a friction-reducing linercomprising polytetrafluoroethylene (PTFE) so as to reduce frictionduring the sliding of respective wires 31 a and 31 b therethrough.Additionally, the wall of catheter 14 is shaped to define a secondarylumen 1422 for passage therethrough of guide member 86 (not shown inFIG. 5 for clarity of illustration, but are shown in FIGS. 1 and 2). Theinner wall of secondary lumen 1422 is coated with a friction-reducingliner comprising polytetrafluoroethylene (PTFE) so as to reduce frictionduring the sliding of guide member 86 therethrough.

Typically, catheter 14 has an inner diameter D3 (or the diameter oflumen 59) of between 4.7 and 5.3 mm (e.g., 5.1 mm) and outer diameter D4of between 6.3 and 6.9 mm (e.g., 6.5 mm or 6.7 mm).

It is to be noted that even though catheter 14 has multiple durometersegments, inner and outer diameters D3 and D4, respectively, remainconstant along a longitudinal length L17 of catheter 14.

Typically, catheter 14 has a length L17 of between 1000 and 1500 mm,e.g., between 1190 and 1210 mm, e.g., 1200 mm. Uniform durometer section1407 has a length L16 that is between 900 and 1400 mm, e.g., between1110 and 1130 mm, e.g., 1126 mm. Tubular polymer 1416 extends an entirelength L17 of catheter 14. Catheter 14 is surrounded by a braided mesh1417, which typically comprises a flexible metal (e.g., stainless steel304 or nitinol). Typically, braided mesh 1417 extends along the lengthof catheter 14 until a proximal portion at which the pull wires 31 a and31 b (not shown for clarity of illustration) are exposed from withinlumens 1421 at a proximal section of catheter 14, e.g., between 993 and1007 mm (e.g., 1000 mm) from distal end 104 of catheter 14.

Section 1410 comprises a distal pull-ring section 1401 in which pullring 13 is disposed. Section 1401 has a length of between 3.5 and 4.5 mm(e.g., 4.04 mm) and has a durometer of between 45D and 63D (e.g., 55D).Such a durometer of section 1401 imparts more hardness and rigidity tothe distal portion of catheter 14 in which pull ring 13 is disposed,such that portion/section 1401 supports ring 13 and protects the distalportion of catheter 14 from the impact of forces applied thereto duringthe pulling of pull ring 13 by the pull wires. Typically, pull ring 13has a length of between 2.5 and 2.6 mm, e.g., 2.54 mm. A distaltransition section 1402 is disposed proximal to section 1401 and has alength L11 of between 1 and 2 mm (e.g., 1.5 mm) and has a durometer ofbetween 63D and 72D (e.g., 72D). The relatively high durometer ofsection 1402 imparts hardness to section 1402 such that pull ring 13 issupported and maintained in place during the pulling of pull ring 13 bythe pull wires. Thus, section 1402 helps overcome high tensile forcesacting on the distal end of catheter 14.

Catheter 14 provides collective bending section 1405 proximally adjacentto section 1402. As shown in the enlarged image, bending section 1405comprises a coil 1418 which is embedded within the tubular polymer 1416.Typically, coil 1418 comprises a flexible metal (e.g., stainless steel304 or nitinol). Coil 1418 imparts efficient and durable bending tobending section 1405. Bending section 1405 has a length L14 of between60 and 70 mm, e.g., 62 mm. Collective bending section 1405 comprisesexposed bending section 1403 and a proximal bending section 1404.

Reference is now made to FIG. 6, which is a schematic illustration of arelative spatial orientation of the steerable distal end portions ofcatheters 12 and 14, respectively. Typically, in a fully-pushed state ofcatheter 14 within catheter 12, as described hereinabove, catheter 14provides exposed distal end portion 114 that extends beyond distal end102 of catheter 12. Distal end portion 114 comprises exposed bendingsection 1403. In the fully-pushed state of catheter 14, exposed bendingsection 1403 is configured to be exposed from and extend beyond distalend 102 of catheter 12, while at least a distal portion of proximalbending section 1404 is configured to remain concentrically disposedwithin the lumen of catheter 12 in general alignment with bendingsection 1203 of catheter 12, as indicated by the broken line in FIG. 6.

Reference is now made to FIGS. 5 and 6. Polymer 1416 at exposed bendingsection 1403 (in FIG. 5) has a durometer of between 20D and 35D (e.g.,25D) which provides a degree of softness at exposed bending section 1403that facilitates bending of section 1403. Additionally, proximal bendingsection 1404 has a durometer of between 25D and 45D (e.g., 35D) whichprovides a degree of softness at exposed bending section 1404 thatfacilitates bending of section 1404. It is to be noted that thedurometer of proximal bending section 1404 is higher than the durometerof exposed bending section 1403. Since the durometer of proximal bendingsection 1404 of catheter 14 is generally similar to the durometer ofbending section 1203 of catheter 12, the steering of the distal endportion of catheter 14 (and of exposed distal portion 114) and thebending of bending section 1405 of catheter 14 (especially the bendingof exposed bending section 1403) does not substantially influence thebending and spatial orientation of bending section 1203 at the distalend portion of catheter 12 when catheter 14 is disposed within catheter12.

Typically, bending section 1405 has a maximum bending angle between 100and 140 degrees (e.g., 117 degrees). That is, bending section 1405 canbend between 0 and 140 degrees. For some applications, at least aportion of bending section 1405 has a pre-shaped angle of between 40 and55 degrees (e.g., 45 degrees) so as to reduce force applied to bendingsection 1405 of catheter 14 by pull wires 31 a and 31 b.

Reference is again made to FIG. 5. It is to be noted that only tubularpolymer 1416 and braided mesh 1417 extend proximally and distally beyondbending section 1405.

Proximally adjacent to bending section 1405 is a transition section 1406having a length L15 of between 4 and 6 mm (e.g., 5 mm). Proximallyadjacent to transition section 1406 is uniform durometer section 1407.Uniform durometer section 1407 has a durometer of between 63D and 72D(e.g., 72D). Transition section 1406 has a durometer of between 35D and55D (e.g., 45D) so as to provide a transition from the relatively lowdurometer of proximal bending section 1404 of bending section 1405 tothe relatively high durometer of uniform durometer section 1407. FIG. 5shows the relative position of slit engager 54 with respect to distalend 104 of catheter 14. As described hereinabove, a proximal-most end ofengager 54 is disposed up to 120 mm (e.g., up to 80 mm) from distal end104 of catheter 14.

Typically, the spatial orientation of bending section 1405 is determinedby pulling on pull wires 31 a and 31 b that are disposed within lumens1421 (wires 31 a and 31 b are not shown for clarity of illustration).Bending section 1405, for some alternative applications of the presentinvention, may be pre-shaped to assume a given spatial orientation andthe spatial orientation of section 1405 is additionally determined bypulling on pull wires 31 a and 31 b.

Reference is now made to FIG. 7A, which is a schematic illustration of acatheter 1012 as described hereinabove with regard to catheter 12 withreference to FIG. 4, with the exception that catheter 1012 comprises atubular portion 1250 that is shaped to define slit 52 described herein,in accordance with some applications of the present invention. Tubularportion 1250 comprises a flexible or rigid metal segment that is shapedto provide first coupling 152. For some applications, slit 52 is createdin tubular portion 1250. For other applications, frame 50 (describedhereinabove with reference to FIG. 1) is coupled to tubular portion 1250in alignment with a slit generated therein.

During manufacture of catheter 1012, tubular portion 1250 is positionedlongitudinally and coaxially between segments of section 1205 ofcatheter 1012. That is, a portion of section 1205 is cut in order togenerate intermediate free ends, and tubular portion 1250 is attached atrespective free ends thereof to the intermediate free ends of section1205. For some applications, catheter 1012 is not cut, but rathercatheter 1012 is comprised of two separate parts, each having free endswhich are each coupled to portion 1250. For some applications, theintermediate free ends are coupled to respective metal segments, andtubular portion 1250 is coupled to the metal segments at theintermediate free ends of catheter 12 by being welded to the metalsegments.

Typically, but not necessarily, the metal of portion 1250 is covered byplastic or the polymer of catheter 12, described hereinabove withreference to FIG. 4.

Typically, the pull wires of catheter 12 described hereinabove withreference to FIG. 2, run through secondary lumens in the wall of tubularportion 1250, or adjacently to the wall of portion 1250.

It is to be noted that tubular portion 1250 may be coupled to anysuitable catheter known in the art.

Reference is now made to FIG. 7B, which is a schematic illustration of acatheter 1014 as described hereinabove with regard to catheter 14 withreference to FIG. 5, with the exception that catheter 1014 comprises atubular portion 1450 that is shaped to define engager 54 and tab 56described herein, in accordance with some applications of the presentinvention. Tubular portion 1450 comprises a flexible or rigid metalsegment that is shaped to provide second coupling 154. That is, tubularportion 1450 provides slits 57 (as shown in FIG. 1) which define tab 56and engager 54. Thus, for some applications, tubular portion 1450 andtab 56 are constructed from a single unit by creating slits in tubularportion 1450, and the protrusion of engager 54 is welded or otherwisecoupled to a distal end of tab 56. For other applications, coupling 154comprises a base which defines tab 56 and provides engager 54, and thebase is coupled to tubular portion 1450.

During manufacture of catheter 1014, tubular portion 1450 is positionedlongitudinally and coaxially between segments of section 1407 ofcatheter 1014. That is, a portion of section 1407 is cut in order togenerate intermediate free ends, and tubular portion 1450 is attached atrespective free ends thereof to the intermediate free ends of section1407. For some applications, catheter 1014 is not cut, but rathercatheter 1012 is comprised of two separate parts, each having free endswhich are each coupled to portion 1250. For some applications, theintermediate free ends are coupled to respective metal segments, andtubular portion 1450 is coupled to the metal segments at theintermediate free ends of catheter 14 by being welded to the metalsegments.

Typically, but not necessarily, the metal of portion 1450 is covered byplastic or the polymer of catheter 14, described hereinabove withreference to FIG. 5.

Typically, the pull wires of catheter 14 described hereinabove withreference to FIG. 2, run through secondary lumens in the wall of tubularportion 1450, or adjacently to the wall of portion 1450.

It is to be noted that tubular portion 1450 may be coupled to anysuitable catheter known in the art.

Reference is now made to FIG. 8, which is a schematic illustration of asystem 300 comprising a generally-rigid segment 302 positioned betweencatheters 12 and 14 described herein, in accordance with someapplications of the present invention. Typically, generally-rigidsegment 302 is disposed at an outer surface of catheter 14 and isconfigured to extend between 20 and 40 degrees circumferentially aroundthe outer surface of catheter 14. For some applications, segment 302comprises a metal. Segment 302 is configured to restrict bending ofcatheter 14 in a given plane so as to minimize interference of thebending and steering of catheter 14 on catheter 12. Additionally,segment 302 is configured to minimize the effect of the spatialorientation of catheter 12 on the steering and bending of catheter 14.Thus, segment 302 provides a relative-spatial-orientation-controllingdevice to control the relative spatial orientations of the respectivesteerable distal end portions of catheters 12 and 14.

Generally-rigid segment 302 may be used with catheters 12 and 14independently of or in combination with first and second couplings 152and 154, as described hereinabove with reference to FIGS. 1, 2, and3A-E.

Reference is now made to FIG. 9, which is a schematic illustration of asystem 320 comprising a friction-enhancing element 322 positionedbetween catheters 12 and 14 described herein, in accordance with someapplications of the present invention. Typically, friction-enhancingelement 322 is disposed at an outer surface of catheter 14 and isconfigured to extend between 20 and 40 degrees circumferentially aroundthe outer surface of catheter 14. For some applications,friction-enhancing element 322 comprises a metal or a plastic.Friction-enhancing element 322 is configured to restrict bending ofcatheter 14 in a given plane so as to minimize interference of thebending and steering of catheter 14 on catheter 12. Additionally,friction-enhancing element 322 is configured to minimize the effect ofthe spatial orientation of catheter 12 on the steering and bending ofcatheter 14. Thus, friction-enhancing element 322 provides arelative-spatial-orientation-controlling device to control the relativespatial orientations of the respective steerable distal end portions ofcatheters 12 and 14.

Friction-enhancing element 322 may be used with catheters 12 and 14independently of or in combination with first and second couplings 152and 154, as described hereinabove with reference to FIGS. 1, 2, and3A-E.

Reference is now made to FIGS. 10A-C, which are schematic illustrationsof a system 330 comprising a hypertube section 332 disposed at a distalend of catheter 12 and 14 described herein, in accordance with someapplications of the present invention. Typically, hypertube section 332provides a lumen for passage therethrough of a distal portion ofcatheter 14. Hypertube section 332 is configured to facilitate bendingof the distal portion of catheter 12 in the first plane, as shown inFIGS. 10B-C (e.g., the plane parallel with respect to the valve of thepatient), while restricting bending of catheter 12 the second plane thatis perpendicular with respect to the first plane. As such, during thebending and steering of the distal end portion of catheter 14 in thesecond plane, catheter 12 is restricted from being bent in the secondplane, by hypertube section 332. Thus hypertube section 332 minimizesinterference of the bending and steering of catheter 14 on catheter 12.Additionally, hypertube section 332 is configured to minimize the effectof the spatial orientation of catheter 12 on the steering and bending ofcatheter 14. Thus, hypertube section 332 provides arelative-spatial-orientation-controlling device to control the relativespatial orientations of the respective steerable distal end portions ofcatheters 12 and 14.

Hypertube section 332 may be used with catheters 12 and 14 independentlyof or in combination with first and second couplings 152 and 154, asdescribed hereinabove with reference to FIGS. 1, 2, and 3A-E.

Reference is now made to FIGS. 1 A-B, which are schematic illustrationsof a catheter 340 having multiple steering segments (e.g., first andsecond steering segments 346 and 348, respectively), in accordance withsome applications of the present invention. First steering segment 346comprises a first pull ring 345 that is coupled to respective distalends of first and second first-segment steering wires 344 a and 344 b.Steering wires 344 a and 344 b extend from the distal end of catheter340 toward a proximal portion of catheter 340. Second steering segment348 comprises a second pull ring 343 that is coupled to respectivedistal ends of first and second first-segment steering wires 342 a and342 b. Steering wires 342 a and 342 b extend from pull ring 343 toward aproximal portion of catheter 340.

Segment 346 is configured to be coupled to only steering wires 344 a and344 b. Steering wires 344 a and 344 b pass through respective channelsprovided by pull ring 343.

In response to the pulling of wires 342 a and 342 b steering segments348 is steering in a first plane, and in response to the pulling ofwires 344 a and 344 b steering segments 346 is steering in a secondplane. For applications in which catheter 340 is used to deliver theannuloplasty structure 222 and anchor driver 36 described herein to acardiac valve, segment 348 is configured to be steered in the plane thatis parallel with respect to the valve, and segment 346 is configured tobe steered toward the valve in a second plane that is perpendicular withrespect to the plane of the valve.

For some applications catheter 340 may be introduced withinmulti-component tubular system 10, described hereinabove with referenceto FIGS. 1 and 2, in place of catheters 12 and 14. That is referenceforce tube 19, implant 222, channel 18, and deployment manipulator 61may be advanced within a lumen of catheter 340.

Reference is made to FIGS. 12A-B, which are schematic illustrations ofrotating deployment element 38, as described hereinabove with referenceto FIG. 2, in radially-expanded and radially-compressed states,respectively, in accordance with some applications of the presentinvention. For some applications, rotating deployment element 38 isshaped to define at least two prongs 124A and 124B that extend in adistal direction from a proximal base 122 of the deployment element.Engagement elements 120A and 120B extend in a distal direction fromprongs 124A and 124B, respectively. The engagement elements aretypically male, and, for example, may together have a cross-sectionalshape that is rectangular, e.g., square. Optionally, rotating deploymentelement 38 comprises more than two prongs and two engagement elements,e.g., three or four of each.

Rotating deployment element 38 is typically configured to assume aradially-expanded state as its resting state, as shown in FIG. 12A. Inthis expanded state, engagement elements 120A and 120B, as well asprongs 124A and 124B, are positioned apart from one another. In thisstate, the engagement elements are shaped and sized to engagetool-engaging head 62 of anchor 32, as shown, for example, in FIG. 2.

As shown in FIG. 12B, the rotating deployment element 38 assumes aradially-compressed state, when the engagement elements and prongs aresqueezed together, such as by passing through the engaging opening oftool-engaging head 62 of anchor 32.

Reference is now made to FIGS. 13A-B, which are schematic illustrationsof rotating deployment element 38 engaging tool-engaging head 62 ofanchor 32, with the element 38 in locked and unlocked states,respectively, in accordance with an application of the presentinvention. In accordance with this application, rotating deploymentelement 38 comprises a locking mechanism 128, which is configured toselectively assume locked and unlocked states. When locking mechanism128 assumes the locked state (FIG. 13A), the locking mechanism preventsdisengagement of rotating deployment element 38 from the anchor whichrotating deployment element 38 currently engages. This locking allowsdeployment element 38 to proximally withdraw anchor 32 if necessary,without coming disengaged therefrom. Disengagement is thus preventedeven upon withdrawal of the rotating deployment element in the proximaldirection. When the locking mechanism assumes the unlocked state (FIG.13B), the locking mechanism does not prevent disengagement of therotating deployment element from the anchor upon withdrawal of rotatingdeployment element 38 in the proximal direction. The rotating deploymentelement thus can be disengaged and withdrawn from the anchor in aproximal direction. It is noted that even when the locking mechanismassumes the unlocked state, the rotating deployment element generallydoes not disengage from the anchor unless the rotating deploymentelement is withdrawn in the proximal direction. As mentioned above withreference to FIG. 12A, rotating deployment element 38 is typicallyconfigured to assume a radially-expanded state as its resting state. Inthis radially-expanded state, engagement elements 120A and 120B arepositioned apart from each other, and engage tool-engaging head 62 ofanchor 32. Thereby, even in the unlocked state shown in FIG. 13B,engagement elements 120A and 120B typically remain positioned apart fromeach other.

For some applications, locking mechanism 128 comprises elongate rod 130.In order to cause the locking mechanism to assume the locked position,rod 130 is advanced distally between engagement elements 120A and 120B.The rod holds the engagement elements in their radially-expanded state,as described hereinabove with reference to FIG. 12A, thereby preventingthe engagement elements from assuming the radially-compressed stateshown in FIG. 12B and disengaging from the anchor. In theradially-expanded state, the engagement elements engage a proximalengaging surface 66 of tool-engaging head 62 of anchor 32. In order tocause locking mechanism 128 to assume the unlocked state, rod 130 iswithdrawn proximally from between engagement elements 120A and 120B. Asa result, as deployment element 38 is subsequently pulled in theproximal direction, the engagement elements are pushed together bytool-engaging head 62 (e.g., proximal engaging surface 66 thereof), soas to assume the radially-compressed state shown in FIG. 12B. In theradially-compressed state, the engagement elements do not engage thetool-engaging head of the anchor, and deployment element 38 is therebydecouplable from anchor 32.

Movement of rod 130 proximally and distally is described hereinabovewith reference to FIG. 2. As shown in Section E-E of FIG. 2, a proximalend of rod 130 is coupled to a component of an anchor-release mechanism28 at a proximal end of system 10. Mechanism 28 comprises a housing 135and a finger-engager 131 that is coupled to the proximal end of rod 130.Finger-engager 131 is coupled to a housing 135 via a spring 133 (sectionE-E of FIG. 2). A proximal end of the tube of anchor driver 36 iscoupled to housing 135. As is described hereinbelow, the physicianreleases anchor 32 from deployment element 38 when finger-engager 131 ispulled proximally, thereby pulling rod 130 proximally. When rod 130 ismoved proximally, the distal portion of rod 130 is removed from betweenengagement elements 120A and 120B, and elements 120A and 120B assume theunlocked state described hereinabove.

Providing this selective, actively-controllable engagement and releaseof the anchor allows rotating deployment element 38 to be used tounscrew an already-deployed anchor from the tissue, and/or to proximallywithdraw an anchor, without deployment element 38 unintentionallydisengaging from the anchor head. Such unscrewing or proximal withdrawalmay allow an anchor to be repositioned if it is initially coupled to thetissue in an incorrect location. Rotating deployment element 38 iscapable of performing this redeployment for both (a) the anchor that hasbeen most recently deployed into the tissue, and to which the deploymentelement 38 is still coupled, and (b) an anchor that was previouslydeployed, and from which deployment element 38 has already beendecoupled (and, optionally, even after another anchor has subsequentlybeen deployed). In the latter case, deployment element 38 re-engages theanchor that is to be redeployed. For some applications, such re-engagingoccurs when deployment manipulator/element 38, in its compressed state,reenters the opening of tool-engaging head 62 and coupling elements 120Aand 120B are allowed to assume their radially-expanded states (e.g.,such as by advancing rod 130 therebetween).

Reference is now made to FIGS. 14A-I, which are schematic illustrationsof a procedure for implanting an annuloplasty ring structure 222 torepair a mitral valve 230, in accordance with an application of thepresent invention. This procedure is one exemplary procedure that can beperformed using system 10.

Annuloplasty ring structure 222 is used to repair a dilated valveannulus of an atrioventricular valve, such as mitral valve 230. For someapplications, the annuloplasty ring is configured to be placed onlypartially around the valve annulus (e.g., to assume a C-shape), and,once anchored in place, to be contracted so as to circumferentiallytighten the valve annulus. The annuloplasty ring comprises flexiblesleeve 26 and a plurality of anchors 32. Anchor deployment manipulator61 is advanced into a lumen of sleeve 26, and, from within the lumen,deploys the anchors through a wall of the sleeve and into cardiactissue, thereby anchoring the sleeve around a portion of the valveannulus. For some application, annuloplasty ring structure 222 isimplemented using techniques described in U.S. application Ser. No.12/437,103, filed May 7, 2009 which published as US 2010/0286767 (nowU.S. Pat. No. 8,715,342), and/or U.S. application Ser. No. 12/689,635,filed Jan. 19, 2010 which published as US 2010/0280604 (now U.S. Pat.No. 8,545,553), both of which are assigned to the assignee of thepresent application and are incorporated herein by reference. Asdescribed hereinabove, annuloplasty ring structure 222 comprisesadjusting mechanism 40. The adjusting mechanism comprises a rotatablestructure, such as a spool, arranged such that rotation of the rotatablestructure contracts the implant structure. The implant further comprisesa longitudinal member, such as a wire, which is coupled to the adjustingmechanism. A rotation tool is provided for rotating the rotatablestructure. The tool is configured to be guided along (e.g., over,alongside, or through) the longitudinal member, to engage the rotatablestructure, and to rotate the rotatable structure in response to arotational force applied to the tool.

As shown in FIG. 14A, the procedure typically begins by advancing asemi-rigid guidewire 202 into a right atrium 220 of the patient. Theprocedure is typically performed with the aid of imaging, such asfluoroscopy, transesophageal echo, and/or echocardiography.

As show in FIG. 14B, guidewire 202 provides a guide for the subsequentadvancement of outer catheter 12 therealong and into the right atrium.Once a distal portion of catheter 12 has entered the right atrium,guidewire 202 is retracted from the patient's body. Catheter 12typically comprises a 14-24 F sheath, although the size may be selectedas appropriate for a given patient. Catheter 12 is advanced throughvasculature into the right atrium using a suitable point of origintypically determined for a given patient. For example:

-   -   catheter 12 may be introduced into the femoral vein of the        patient, through an inferior vena cava 223, into right atrium        220, and into a left atrium 224 transseptally, typically through        the fossa ovalis;    -   catheter 12 may be introduced into the basilic vein, through the        subclavian vein to the superior vena cava, into right atrium        220, and into left atrium 224 transseptally, typically through        the fossa ovalis; or    -   catheter 12 may be introduced into the external jugular vein,        through the subclavian vein to the superior vena cava, into        right atrium 220, and into left atrium 224 transseptally,        typically through the fossa ovalis.

For some applications of the present invention, catheter 12 is advancedthrough inferior vena cava 223 of the patient (as shown) and into rightatrium 220 using a suitable point of origin typically determined for agiven patient.

Catheter 12 is advanced distally until the sheath reaches theinteratrial septum, and guidewire 202 is withdrawn, as shown in FIG.14C.

As shown in FIG. 14D, a resilient needle 206 and a dilator (not shown)are advanced through catheter 12 and into the heart. In order to advancecatheter 12 transseptally into left atrium 224, the dilator is advancedto the septum, and needle 206 is pushed from within the dilator and isallowed to puncture the septum to create an opening that facilitatespassage of the dilator and subsequently catheter 12 therethrough andinto left atrium 224. The dilator is passed through the hole in theseptum created by the needle. Typically, the dilator is shaped to definea hollow shaft for passage along needle 206, and the hollow shaft isshaped to define a tapered distal end. This tapered distal end is firstadvanced through the hole created by needle 206. The hole is enlargedwhen the gradually increasing diameter of the distal end of the dilatoris pushed through the hole in the septum. As shown in FIG. 4, forexample, a distal-most end 102 of catheter 12 is tapered so as tofacilitate passage of the distal portion of catheter 12 through theopening in the septum.

The advancement of catheter 12 through the septum and into the leftatrium is followed by the extraction of the dilator and needle 206 fromwithin catheter 12, as shown in FIG. 14E. Once the distal portion ofcatheter 12 is disposed within atrium 224, the steerable distal endportion of catheter 12 (which includes at least a portion of bendingsection 1203, as described hereinabove with reference to FIGS. 4 and 6)is steered in a first plane that is parallel to a plane of the annulusof mitral valve 230. Such steering moves the distal end portion ofcatheter 12 in a direction from the interatrial septum towardsurrounding walls of the atrium, as indicated by the arrow in atrium224. As described hereinabove, steering of the distal portion ofcatheter 12 is performed via steering knob 210 of handle 22 in handleportion 101 (in FIGS. 1 and 2).

As shown in FIG. 14F, annuloplasty ring structure 222 (not shown forclarity of illustration, with anchor deployment manipulator 61 therein)is advanced through guide catheter 14, which is in turn, advancedthrough catheter 12 into left atrium 224. As shown in FIG. 14F, exposeddistal end portion 114 of catheter 14 extends beyond distal end 102 ofcatheter 12. Exposed distal end portion 114 is then (1) steered towardthe annulus of valve 230 along a plane that is perpendicular withrespect to the steering plane of catheter 12 and that is perpendicularwith respect to valve 230, and is (2) bent, via bending section 1403 (asdescribed hereinabove with reference to FIGS. 5 and 6) toward valve 230.As described hereinabove, steering of the distal portion of catheter 14is performed via steering knob 214 of handle 24 in handle portion 101(in FIGS. 1 and 2).

As shown in FIG. 14G, a distal end 251 of sleeve 26 is positioned in avicinity of a left fibrous trigone 242 of an annulus 240 of mitral valve230. (It is noted that for clarity of illustration, distal end 251 ofsleeve 26 is shown schematically in the cross-sectional view of theheart, although left trigone 242 is in reality not located in the showncross-sectional plane, but rather out of the page closer to the viewer.)Alternatively, the distal end of sleeve 26 is positioned in a vicinityof a right fibrous trigone 244 of the mitral valve (configuration notshown). Further alternatively, the distal end of the sleeve is notpositioned in the vicinity of either of the trigones, but is insteadpositioned elsewhere in a vicinity of the mitral valve, such as in avicinity of the anterior or posterior commissure. Once positioned at thedesired site near the selected trigone, deployment manipulator 61deploys a first anchor 32 through the wall of sleeve 26 (by penetratingthe wall of the sleeve in a direction in a direction parallel to acentral longitudinal of deployment manipulator 61, or anchor driver 36,through the distal end of channel 18, and/or parallel to centrallongitudinal axis of tissue coupling element 60 of anchor 32) intocardiac tissue near the trigone, using the techniques describedhereinabove with reference to FIGS. 12A-B and 13A-B. Following thedeployment of anchor 32 in the cardiac tissue, deployment element 38 isdecoupled from anchor 32 by moving rod 130 proximally, as describedhereinabove with reference to FIGS. 2, 12A-B, and 13A-B.

Anchors 32 are typically deployed from a distal end of manipulator 61while the distal end is positioned such that a central longitudinal axisthrough the distal end of manipulator 61 forms an angle with a surfaceof the cardiac tissue of between about 20 and 90 degrees, e.g., between45 and 90 degrees, such as between about 75 and 90 degrees, such asabout 90 degrees. Typically, anchors 32 are deployed from the distal endof manipulator 61 into the cardiac tissue in a direction parallel to thecentral longitudinal axis through the distal end of manipulator 61. Suchan angle is typically provided and/or maintained by channel 18 beingmore rigid than sleeve 26. Distal end 17 (shown in FIG. 2) of channel 18is typically brought close to the surface of the cardiac tissue (and thewall of sleeve 26 that is disposed against the surface of the cardiactissue), such that little of each anchor 32 is exposed from channel 18before penetrating the sleeve and the tissue. For example, distal end 17of channel 18 may be placed (e.g., pushed) against the wall of thesleeve, sandwiching the sleeve against the cardiac tissue.

For some applications, this placement of distal end 17 of channel 18against the cardiac tissue (via the wall of the sleeve), stabilizes thedistal end during deployment and anchoring of each anchor 32, andthereby facilitates anchoring. For some applications, pushing of distalend 17 against the cardiac tissue (via the wall of the sleeve)temporarily deforms the cardiac tissue at the site of contact. Thisdeformation may facilitate identification of the site of contact usingimaging techniques (e.g., by identifying a deformation in the borderbetween cardiac tissue and blood), and thereby may facilitate correctpositioning of the anchor.

For some applications of the present invention, anchors 32 may bedeployed from a lateral portion of manipulator 61.

Reference is now made to FIGS. 14G and 2. Following the deployment ofthe first anchor, a distal portion of sleeve 26 is decoupled from aportion of implant-decoupling channel 18. In order to decouple theportion of sleeve 26 from outer surface of channel 18, (1) channel 18 ispulled proximally, while (2) reference-force tube 19 is maintained inplace in a manner in which a distal end of tube 19 provides a referenceforce to sleeve 26 in order to facilitate retraction freeing of asuccessive portion of sleeve 26 from around channel 18. In order todecouple sleeve 26 from the outer surface of channel 18, (1) channel 18is pulled proximally, while (2) reference-force tube 19 is maintained inplace. An indicator 2120 (shown herein with reference to FIGS. 30A-B) onhandle 126 provides an indication of how much channel 18 is withdrawnfrom within sleeve 26 (i.e., how much the delivery tool is decoupledfrom sleeve 26, and how much sleeve has advanced off channel 18 andagainst tissue). A proximal end of channel 18 is coupled to a knob 94(FIG. 2) which adjusts an axial position of channel 18 proximally anddistally with respect to reference-force tube 19 and sleeve 26. As shownin FIG. 14H, deployment manipulator 61 is repositioned along annulus 240to another site selected for deployment of a second anchor 32. Referenceis now made to FIGS. 1 and 14H. Such repositioning of manipulator 61 isaccomplished by:

(1) the steering of the distal end portion of catheter 12 (e.g., bysteering knob 210 of handle 22) in the first plane that is parallel withrespect to annulus 240 of valve 230 to a desired spatial orientation andin a manner which bends bending section 1203 of catheter 12,

(2) the steering of the distal end portion of portion of catheter 14(e.g., by steering knob 214 of handle 24) in the second plane that isperpendicular with respect to annulus 240 of valve 230 to a desiredspatial orientation, and in a manner which bends bending section 1405 ofcatheter 14 (specifically bending section 1403),

(3) by axially moving catheter 14 with respect to catheter 12 via knob216,

(4) by axially moving the stand supporting handles 22 and 24 to moveboth catheters 12 and 14,

(5) by moving tube 19 and sleeve 26 axially by sliding mount 93 alongtrack 90 via knob 95, and/or

(6) by moving channel 18 relative to tube 19 by actuating knob 94.

Typically, the first anchor is deployed most distally in the sleeve(generally at or within a few millimeters of the distal tip of thesleeve), and each subsequent anchor is deployed more proximally, suchthat the sleeve is gradually decoupled from channel 18 of deploymentmanipulator 61 in a distal direction during the anchoring procedure(i.e., channel 18 is withdrawn from within sleeve 26, and handle 126 ismoved distally so as to retract the tool to make the successive proximalportion sleeve 26 ready for implantation of a subsequent anchor). Thealready-deployed first anchor 32 holds the anchored end of sleeve 26 inplace, so that the sleeve is drawn from the site of the first anchortowards the site of the second anchor. Typically, as sleeve 26 isdecoupled from channel 18, deployment manipulator 61 is moved generallylaterally along the cardiac tissue, as shown in FIG. 14H. Deploymentmanipulator 61 deploys the second anchor through the wall of sleeve 26into cardiac tissue at the second site. Depending on the tension appliedbetween the first and second anchor sites, the portion of sleeve 26therebetween may remain tubular in shape, or may become flattened, whichmay help reduce any interference of the ring with blood flow.

As shown in FIG. 14I, deployment manipulator 61 is repositioned alongthe annulus to additional sites, at which respective anchors aredeployed, until the last anchor is deployed in a vicinity of rightfibrous trigone 244 (or left fibrous trigone 242 if the anchoring beganat the right trigone). Alternatively, the last anchor is not deployed inthe vicinity of a trigone, but is instead deployed elsewhere in avicinity of the mitral valve, such as in a vicinity of the anterior orposterior commissure. Then, system 10 is removed, leaving behind guidemember 86. A rotation tool (not shown) is then threaded over andadvanced along guide member 86 toward adjusting mechanism 40 and is usedto rotate the spool of adjusting mechanism 40, in order to tightenstructure 222 by adjusting a degree of tension of contracting member226, as is described hereinbelow with reference to FIG. 17. Once thedesired level of adjustment of structure 222 is achieved (e.g., bymonitoring the extent of regurgitation of the valve underechocardiographic and/or fluoroscopic guidance), the rotation tool andguide member 86 are removed from the heart. For some applications, adistal portion of guide member 86 may be left within the heart of thepatient and the proximal end may be accessible outside the body, e.g.,using a port. For such applications, adjusting mechanism 40 may beaccessed at a later stage following initial implantation and adjustmentof ring structure 222.

As shown, sleeve 26 of ring structure 222 comprises a plurality ofradiopaque markers 25, which are positioned along the sleeve atrespective longitudinal sites to indicate anchor-designated targetareas. The markers may provide an indication in a radiographic image(such as a fluoroscopy image) of how much of sleeve 26 has been deployedat any given point during an implantation procedure, in order to enablesetting a desired distance between anchors 32 along the sleeve 26.

Alternatively, annuloplasty ring structure 222 is implanted by right orleft thoracotomy, mutatis mutandis.

For some applications of the present invention, following implantationof sleeve 26 along the annulus, an excess portion of sleeve 26 may bepresent at the proximal portion of sleeve. In such applications,following removal of manipulator 61, a cutting tool (not shown) may beadvanced within channel 18 and into the lumen of the excess portions ofsleeve 26 (e.g., from within sleeve 26) in order to cut the sleeveproximal to the proximal-most-deployed anchor 32.

Reference is made to FIG. 15. For some applications of the presentinvention, annuloplasty ring structure 222 is used to treat anatrioventricular valve other than the mitral valve, i.e., tricuspidvalve 231, using system 10 in a similar method as described hereinabovewith reference to FIGS. 14A-I, in accordance with some applications ofthe present invention.

For these applications, ring structure 222 and other components ofsystem 10 described hereinabove as being placed in the left atrium areinstead placed in the right atrium 220. FIG. 15 shows accessing rightatrium 220 through superior vena cava 225 by way of illustration and notlimitation. Components of system 10 may be advanced into the rightatrium through inferior vena cava 223.

Although annuloplasty ring structure 222 is described hereinabove asbeing placed in an atrium, for some application the ring is insteadplaced in either the left or right ventricle.

Accordingly, it is noted that, annuloplasty ring structure 222 and othercomponents of system 10 described hereinabove and methods shown in theapplication can be used on any cardiac valve (e.g., the mitral,tricuspid, aortic, and/or pulmonary).

Reference is made to FIGS. 16A-B, which are schematic illustrations of amultiple-anchor deployment system 110 which is configured to be used incombination with anchor driver 36, as described hereinabove withreference to FIGS. 1 and 2, in accordance with an application of thepresent invention. In this configuration, an anchor restrainingmechanism 70 typically comprises one or more distal tabs 72 fortemporarily restraining the distal-most anchor 32 currently stored in ananchor storage area 76 from advancing in the distal direction. Thedistal tabs may be cut out of a flexible outer tube 34, as shown, orthey may be provided as separate elements coupled to the outer tube. Thedistal tabs apply a force in a radially-inward direction against adistal portion of anchor 32, gently squeezing against the distalportion. The force is sufficient to prevent distal motion of distal-mostanchor 32 and the other anchors currently stored in anchor storage area76, which otherwise would be advanced distally by passive force appliedthereto by other anchors in storage area 76. However, theradially-inward force is insufficient to prevent distal advancement ofdistal-most anchor 32 when the anchor is engaged and advanced distallyby rotating deployment element 38, as described herein. For someapplications, anchor restraining mechanism 70 comprises two distal tabs72, typically on opposite sides of the outer tube (typically axiallyaligned with each other), as shown, while for other applications, theanchor restraining mechanism comprises exactly one distal tab, or threeor more distal tabs, e.g., three or four distal tabs (typically axiallyaligned with one another).

Typically, for applications in which system 10 comprises multiple-anchordeployment system 110, outer tube 34 is disposed between anchor driver36 and channel 18 (shown in FIGS. 1-2). Typically, a distal anchormanipulation area 75 is provided, which is typically flexible andsteerable. Typically, only one anchor at a time is deployed throughanchor manipulation area 75 and into the tissue of the patient, suchthat no more than exactly one anchor is within anchor manipulation area75 at any given time. As a result, anchor manipulation area 75 retainsits flexibility. Because the anchors are typically rigid, when more thanone of the anchors are longitudinally contiguously positioned withinstorage area 76, the area of the tool in which the anchors arepositioned becomes fairly stiff, substantially losing the flexibility itwould otherwise have. Thus, while anchor storage area 76 is fairlyrigid, anchor manipulation area 75 remains flexible because it onlycontains exactly one anchor at a given time. The stiffness of the areaof the tool in which the anchors are positioned also may enable the userto better control the exact location of distal-most anchor 32 currentlystored in anchor storage area 76.

Anchor restraining mechanism 70 comprises a plurality of sets 73 ofproximal tabs 74, labeled 73A, 73B, 73C, 73D, and 73E in FIGS. 16A-B.Each set of proximal tabs 74 engages exactly one anchor 32. For example,the distal ends of proximal tabs 74 of set 73A engage the proximal endof the tool-engaging head of distal-most anchor 32, and the distal endsof proximal tabs 74 of set 73B engage the proximal end of thetool-engaging head of second-to-distal-most anchor 32.

Sets 73 thus provide respective anchor storage locations. Therefore, theanchor restraining mechanism comprises a number of sets 73 greater thanor equal to the number of anchors 32 initially stored in anchor storagearea 76. For some applications, anchor restraining mechanism 70comprises between 6 and 20 sets 73, such as between 8 and 16 sets 73.For some applications, each of sets 73 comprises two proximal tabs 74,typically on opposite sides of the outer tube (typically axially alignedwith each other), as shown, while for other applications, each of thesets comprises exactly one proximal tab, or three or more proximal tabs,e.g., three or four proximal tabs (typically axially aligned with oneanother).

For some applications, each of sets 73 (except the proximal-most set 73)additionally functions as a distal tab 72 for the anchor proximallyadjacent to the set. For example, set 73A, in addition to engagingdistal-most anchor 32A, also prevents distal motion ofsecond-to-distal-most anchor 32.

Each of anchors 32 remains in place in its initial, respective anchorstorage location in anchor storage area 76, until the anchor isindividually advanced out of anchor storage area 76 during deployment bydeployment manipulator 61.

The anchor to be deployed is the distal-most one of the anchors storedin anchor storage area 76, and is initially restrained in the anchorstorage area by anchor restraining mechanism 70. Anchor driver 36 isadvanced in a distal direction until rotating deployment element 38directly engages tool-engaging head 62 of the anchor (by “directlyengages,” it is meant that rotating deployment element 38 comes indirect contact with the anchor, rather than indirect contact via one ormore of the other anchors). Rotating deployment element 38 assumes itsradially-expanded state, as described hereinbelow with reference toFIGS. 12A and 13A, to enable this engagement.

In order to deploy anchors 32, anchor driver 36 is advanced in thedistal direction, until rotating deployment element 38 brings the anchorinto contact with the tissue of the patient at a first site. Forexample, the tissue may be cardiac tissue. Typically, deploymentmanipulator 61 is configured such that, as rotating deployment element38 advances each of the anchors in the distal direction, only the singleanchor 32 currently being advanced is within distal anchor manipulationarea 75. Rotating deployment element 38 is rotated, in order to screwhelical tissue coupling element 60 of the anchor into the tissue. Forsome applications, rotating deployment element 38 is rotated by rotatinganchor driver 36. For other applications, rotating deployment element 38is rotated by rotating an additional rotation shaft provided withinanchor driver 36, which additional shaft is coupled to rotatingdeployment element 38. Rotation of rotating deployment element 38typically rotates only the anchor currently engaged by the deploymentelement, while the other anchors still stored in the storage areatypically are not rotated.

For applications in which system 10 comprises multiple-anchor deploymentsystem 110, deployment manipulator 61 comprises anchor driver 36,deployment element 38, and outer tube 34.

Typically, anchor 32 is deployed from the distal end of outer tube 34 oftool 30 into cardiac tissue in a direction parallel to a centrallongitudinal axis of outer tube 34 through the distal end of tube 34,and/or parallel to central longitudinal axis of tissue coupling element60 of anchor 32, as described herein.

The evacuation of the distal-most anchor from anchor restrainingmechanism 70 frees up the anchor restraining mechanism for the nextdistal-most anchor remaining in anchor storage area 76.

After the distal-most anchor has been coupled to the tissue, rotatingdeployment element 38 is disengaged from the anchor by withdrawing therotating deployment element in a proximal direction. As the rotatingdeployment element passes through the next anchor in the proximaldirection (i.e., the anchor positioned at set 73A), the rotatingdeployment element is squeezed by the engaging opening of tool-engaginghead 62 of the next anchor, causing the rotating deployment element toassume its radially-compressed state, as described hereinbelow withreference to FIGS. 12B and 13B.

Deployment element 38 is repositioned to deploy a second anchor 32 at asecond site of the tissue, different from the first site. Suchrepositioning is typically accomplished using the steering functionalityof catheters 12 and 14, as described hereinabove. The steps of thedeployment method are repeated, until as many anchors 32 as desired havebeen deployed, at respective sites, e.g., a first site, a second site, athird site, a fourth site, etc.

Reference is now made to FIG. 17, which is a schematic illustrationshowing a relationship among individual components of adjustingmechanism 40, in accordance with some applications of the presentinvention. Adjusting mechanism 40 is shown as comprising spool housing44 which defines an upper surface 160 and a lower surface 176 defining arecessed portion (as described with regard to recess 142 with referenceto FIG. 3). A spool 246 is configured to be disposed within housing 44and defines an upper surface 178, a lower surface 180, and a cylindricalbody portion disposed vertically between surfaces 178 and 180. Thecylindrical body portion of spool 246 is shaped to define a channelwhich extends from a first opening at upper surface 178 to a secondopening at lower surface 180.

Typically, spool 246 is configured to adjust a perimeter of annuloplastyring structure 222 by adjusting a degree of tension of contractingmember 226 that is coupled at a first portion of member 226 to spool246. As described hereinabove, contracting member 226 extends alongsleeve 26 and a second portion of contracting member 226 (i.e., a freeend portion) is coupled to a portion of sleeve 26 such that uponrotation of the spool in a first rotational direction, the portion ofsleeve 26 is pulled toward adjusting mechanism 40 in order to contractannuloplasty ring structure 222. It is to be noted that the contractionof structure 222 is reversible. That is, rotating spool 246 in a secondrotational direction that opposes the first rotational direction used tocontract the annuloplasty structure, unwinds a portion of contractingmember 226 from around spool 246. Unwinding the portion of contractingmember 226 from around spool 246 thus feeds the portion of contractingmember 226 back into a lumen of sleeve 26 of structure 222, therebyslackening the remaining portion of contracting member 226 that isdisposed within the lumen sleeve 26. Responsively, the annuloplastystructure gradually relaxes and expands (i.e., with respect to itscontracted state prior to the unwinding).

Lower surface 180 of spool 246 is shaped to define one or more (e.g., aplurality, as shown) of recesses 182 which define structural barrierportions 188 of lower surface 180. It is to be noted that any suitablenumber of recesses 182 may be provided, e.g., between 1 and 10 recesses.For some applications, but not necessarily, recesses 182 are providedcircumferentially with respect to lower surface 180 of spool 246.

Typically, spool 246 comprises a locking mechanism 145. For someapplications, locking mechanism 145 is coupled, e.g., welded, at leastin part to a lower surface of spool housing 44. Typically, lockingmechanism 145 defines a mechanical element having a planar surface thatdefines slits 1158. The surface of locking mechanism 145 may also becurved, and not planar. Locking mechanism 145 is shaped to provide aprotrusion 156 which projects out of a plane defined by the planarsurface of the mechanical element. The slits define a depressibleportion 1128 of locking mechanism 145 that is disposed in communicationwith and extends toward protrusion 156.

In a resting state of locking mechanism 145 (i.e., a locked state ofspool 246), protrusion 156 is disposed within a recess 182 of spool 246.Additionally, in the locked state of spool 246, protrusion 156 isdisposed within the recess of housing 44.

Depressible portion 1128 is aligned with the opening at lower surface180 of spool 246 and is moveable in response to a force applied theretoby a distal force applicator 88 that extends in a distal direction froma distal portion of longitudinal guide member 86. That is, distal forceapplicator 88 is configured to be disposed within the channel of spool246. A distal end of applicator 88 is configured to push on depressibleportion 1128 in order to move depressible portion 1128 downward so as todisengage protrusion 156 from within a recess 182 of spool and to unlockspool 246 from locking mechanism 145.

It is to be noted that the planar, mechanical element of lockingmechanism 145 is shown by way of illustration and not limitation andthat any suitable mechanical element having or lacking a planar surfacebut shaped to define at least one protrusion may be used together withlocking mechanism 145.

A cap 1044 is provided that is shaped to define a planar surface and anannular wall having an upper surface 244 that is coupled to, e.g.,welded to, lower surface 176 of spool housing 44. The annular wall ofcap 1044 is shaped to define a recessed portion 1144 of cap 1044 that isin alignment with the recessed portion of spool housing 44. Lockingmechanism 145 is disposed between lower surface 180 of spool 246 and theplanar surface of cap 1044.

In an unlocked state of adjusting mechanism 40, protrusion 156 oflocking mechanism 145 is disposed within recessed portion 1144 of cap1044. In the unlocked state, force applicator 88 extends through spool246 and pushes against depressible portion 1128 of locking mechanism145. The depressible portion is thus pressed downward, freeingprotrusion 156 from within a recess 182 defined by structural barrierportions 188 of the lower portion of spool 246. Additionally, protrusion156 is freed from within the recessed portion of spool housing 44. As aresult, adjusting mechanism 40 is unlocked, and spool 246 may be rotatedwith respect to spool housing 44.

Cap 1044 functions to restrict distal pushing of depressible portion1128 beyond a desired distance so as to inhibit deformation of lockingmechanism 145. For applications in which adjusting mechanism 40 isimplanted in heart tissue, cap 1044 also provides an interface betweenadjusting mechanism 40 and the heart tissue. This prevents interferenceof heart tissue on adjusting mechanism 40 during the locking andunlocking thereof. Additionally, cap 1044 prevents damage to hearttissue by depressible portion 1128 as it is pushed downward.

Spool 246 is shaped to define a rotation-facilitating head 170, or adriving interface. A rotation tool (not shown) is configured to slidedistally along guide member 86 to engage head 170 of spool 246. Therotation tool is configured to rotate spool 246 by applying rotationalforce to head 170. A friction-reducing ring 172 is disposed betweenupper surface 178 of spool 246 and the inner surface of upper surface160 of spool housing 44.

For some applications, as described herein, guide member 86 is notcoupled to spool 246. For such applications the rotation tool used torotate spool 246 may be shaped to provide a distal force applicator(similar to distal force applicator 88) configured to unlock spool 246from locking mechanism 145. During the unlocked state, spool 246 may bebidirectionally rotated.

Following rotation of spool 246 such that contracting element/member 226is pulled sufficiently to adjust the degree of tension of contractingelement/member 226 so as treat tissue of the ventricle as describedherein, spool 246 is then locked in place so as to restrict rotation ofspool 246. Force applicator 88 is removed from within the channel ofspool 246, and thereby, depressible portion 1128 returns to its restingstate. As depressible portion 1128 returns to its resting state,protrusion 156 is introduced within one of the plurality of recesses 182of lower surface 180 of spool 246 and within the recess of housing 44,and thereby restricts rotation of spool 246.

Spool 246 is shaped so as to provide a hole 242 or other couplingmechanism for coupling a first portion of contracting element/member 226to spool 246, and thereby to adjusting mechanism 40.

Reference is now made to FIGS. 18A-D, which are schematic illustrationsof an indicator and locking system 1700 comprising (1) a protrusion 1724coupled to guide-catheter handle 24, and (2) a housing 1702, or cradle,shaped to define a groove 1704 configured to receive protrusion 1724, inaccordance with some applications of the present invention. System 1700is configured to provide an indication (i.e., to act as an indicator),at a proximal location outside the body of the patient, of the couplingof first and second couplings 152 and 154 of outer catheter 12 and guidecatheter 14, respectively (i.e., when engager 54 is received within slit52 at the distal end portions of catheters 14 and 12, respectively).Additionally, system 1700 is configured to rotationally lock catheter 12to catheter 14, as is described hereinbelow.

Housing 1702 comprises a handle portion that is coupled to a proximalend of catheter 12. As shown, groove 1704 is shaped to define a curvedgroove along a lateral portion of housing 1702. Groove 1704 extendsbetween 45 and 135 rotational degrees, e.g., 90 degrees, as shown.

As described hereinabove with reference to FIGS. 1-2, proximal handleportion 101 is supported by a stand having support legs 91 (i.e., firstleg 91 a and second leg 91 b, as shown in FIGS. 18A-D). As shown inFIGS. 18A-D, first leg 91 a (which is configured to receiveguide-catheter handle 24) provides housing 1702. As describedhereinabove, guide catheter 14 is first advanced within the lumen ofouter catheter 12 when the physician places the distal end of catheter14 within the lumen of catheter 12 (via outer-catheter handle 22) andadvances handle 24 (coupled to the proximal end of catheter 14) towardhandle 22, as indicated by the arrow in FIG. 18A. As describedhereinabove with reference to FIGS. 3A-B, since the lumen of catheter 12is free from any protrusions or recessed portions, and since engager 54is depressible by tab 56, catheter 14 is configured to enter the lumenof catheter 12 in any rotational configuration thereof. As handle 24 isadvanced toward handle 22, protrusion 1724 of handle 24 advances towardgroove 1704. Groove 1704 is shaped to provide a protrusion-accesslocation 1706 and a protrusion-locking location 1708, which locationsare typically but not necessarily spaced 90 degrees apart.Protrusion-locking location 1708 is shaped to provide a depressiblelocking element 1710 which comprises a depressible pin to lockprotrusion 1724 in place, as is described hereinbelow.

As shown in FIG. 18B, when handle 24 has been pushed distally towardhandle 22, protrusion 1724 advances toward groove 1704 in order toengage protrusion-access location 1706 thereof. Depending on therotational orientation of handle 24 with respect to handle 22, thephysician may need to rotate handle 24 to bring protrusion 1724 inalignment with protrusion-access location 1706 of groove 1704. Onceprotrusion 1724 is in alignment with protrusion-access location 1706,handle 24 is further pushed distally in order to engage protrusion 1724with protrusion-access location 1706 of groove 1704. Once protrusion1724 is located within protrusion-access location 1706 of groove 1704,engager 54 is disposed in proximity with slit 52 (e.g., at thelongitudinal site at which coupling 152 is disposed). As shown in theenlarged image at the distal end portion of system 10 and in sectionA-A, when protrusion 1724 is located within protrusion-access location1706 of groove 1704, engager 54 of catheter 14 is rotationally offsetwith respect to slit 52 of catheter 12 by generally the same rotationaldegree by which protrusion-access location 1706 and protrusion-lockinglocation 1708 are rotationally spaced (e.g., 90 degrees).

FIG. 18C shows rotation of catheter 14 with respect to catheter 12, inresponse to rotation of handle 24 with respect to handle 22, in thedirection indicated by the arrow. As handle 24 is rotated, protrusion1724 slides within groove 1704 toward protrusion-locking location 1708,as shown in the enlarged image of a portion of handle 24. As shown inthe enlarged section of the distal end portion of system 10 and insection A-A, as protrusion 1724 is being advanced towardprotrusion-locking location 1708, engager 54 is brought closer to slit52, so as to be rotationally offset with respect to slit 52 by fewerdegrees than when protrusion 1724 is located at protrusion-accesslocation 1706.

FIG. 18D shows system 1700 following the rotation of handle 24 so as toposition protrusion 1724 within protrusion-locking location 1708, inorder to rotationally lock catheter 12 to catheter 14. As protrusion1724 advances toward location 1708, protrusion 1724 pushes lockingelement 1710. For some applications, locking element 1710 isspring-loaded, and is configured to return to a resting state (as shownin FIG. 18D) in the absence of force applied thereto. Thus, onceprotrusion 1724 has advanced beyond locking element 1710 intoprotrusion-locking location 1708, element 1710 returns to its restingstate, and inhibits protrusion from returning toward protrusion-accesslocation 1706. That is, locking element 1710 is only depressible whenprotrusion 1724 advanced from protrusion-access location 1706 towardprotrusion-locking location 1708. Thereby, in the state shown in FIG.18D, catheters 12 and 14 are rotationally locked (1) by insertion ofengager 54 within slit 52, as shown in the enlarged section of thedistal end portion of system 10 and in section A-A, and (2) by insertionof protrusion 1724 within protrusion-locking location 1708, as shown inthe enlarged section of the proximal portion of system 10. In such amanner, groove 1704, protrusion 1724, and locking element 1710 of system1700 rotationally lock catheters 12 and 14 and also prevents accidentalmovement of handle 24 with respect to handle 22. System 1700 (e.g.,groove 1704 and protrusion 1724 thereof) typically further facilitatesrotational locking of catheters 12 and 14, by acting as an indicatorthat provides the physician with an extracorporeal indication of theintracorporeal juxtaposition of couplings 152 and 154 (e.g., anindication of the state of locking of the couplings).

For some applications of the invention, housing 1702, groove 1704, andprotrusion 1724 are used in the absence of couplings 152 and 154.

Reference is now made to FIGS. 19A-B, which are schematic illustrationsof system 10 and a sleeve-deployment indicator 2120, in accordance withsome applications of the present invention. As described hereinabove, inorder to release sleeve 26 from channel 18, knob 94 is rotated whilehandle 126 is kept stationary. Such rotation keeps reference-force tube19 stationary while adjusting a proximal and distal position of channel18 with respect to tube 19. As knob 94 is rotated in a first rotationaldirection, channel 18 is withdrawn proximally. Additionally, handle 126is moved distally such that reference-force tube 19 is advanced distallyto expose sleeve 26 from within catheter 14 such that it reaches theannulus and/or push a portion of sleeve 26 off of channel 18, as channel18 is withdrawn proximally. Responsively, sleeve 26 is advanced off ofchannel 18 and along the annulus of the valve in order to implant asubsequent anchor. In the state shown in FIG. 19A, sleeve 26 remainswithin catheter 14 at the distal end of system 10 (only adjustingmechanism 40 is exposed), and therefore indicator 2120 is exposed onlyslightly proximally. As shown in FIG. 19B, sleeve 26 is entirely exposedfrom within catheter 14 and has been fully advanced off of channel 18(at the distal end of system 10), and therefore, indicator 2120 is fullyexposed at the proximal end of system 10, indicating that sleeve 26 hasbeen released and advanced entirely off of channel 18 (i.e., channel 18has been withdrawn fully from within sleeve 26). Indicator 2120 therebyacts as an indicator that provides the physician with an extracorporealindication of the intracorporeal juxtaposition of channel 18, tube 19,and sleeve 26 (e.g., extracorporeal indication of the state ofdeployment of tube 26). For some applications, indicator 2120 is coupledto reference-force tube 19.

It is to be noted that the numeric gradation shown on indicator 2120 inFIGS. 19A-B is purely an example, and that indicator 2120 mayalternatively or additionally comprise other indicators including, butnot limited to, numeric, non-numeric gradated, and color indicators.

Reference is made to FIG. 20, which is a schematic illustration of asystem 2600 for coupling pull ring 11 of catheter 12 to pull wires 29 aand 29 b, in accordance with some applications of the invention. View Ashows system 2600 with catheters 12 and 14 themselves removed (e.g., toillustrate the relative positioning of the pull ring and pull wires),and view B shows an exploded view of system 2600. As describedhereinabove (e.g., with reference to FIGS. 1-2), pull ring 11 and pullwires 29 a and 29 b are disposed within catheter 12, and configured suchthat adjusting a degree of tension of the pull wires (e.g., by rotatingknob 210) applies a force to the pull ring, which thereby steers thecatheter (i.e., the distal end thereof). For example, increasing tensionon pull wire 29 a steers the catheter toward the side on which pull wire29 a is disposed.

Typically, the pull wires are coupled to the pull ring by welding. Forsome applications, the pull ring defines two or more recesses 2604 inwhich a respective pull wire (e.g., a distal end thereof) is disposed,so as to increase the surface area of contact between the pull ring andthe pull wire, and thereby to facilitate the coupling therebetween.

For some applications, and as shown in FIG. 20, a the coupling of eachpull wire to the pull ring is further facilitated (e.g., reinforced) bya respective cap 2602 (e.g., a cap 2602 a and a cap 2602 b). Cap 2602bridges at least part of recess 2604, and thereby further holds therespective pull wire within the recess. Cap 2602 is typically welded tothe pull ring, and further typically also to the pull wire. It ishypothesized that system 2600 provides a strong coupling between thepull wires and the pull ring, and thereby advantageously facilitates theapplication of strong tensile forces by the pull wires on the pull ring,and/or a large angle of steering of the catheter.

It is to be noted that system 2600 may be used to couple other pullwires to other pull rings, such as to couple pull wires 31 a and 31 b topull ring 13, mutatis mutandis. It is to be further noted that, althoughFIG. 20 shows the coupling wires being coupled to a recess in the outersurface of the pull ring, for some applications, the coupling wires arecoupled to a recess in the inner surface of the pull ring.

Reference is again made to FIGS. 1-20. It is to be noted that followingimplantation of the annuloplasty structures described herein, thedimensions of the annuloplasty structures may be adjusted remotely andwhile the patient is not on a cardio-pulmonary bypass pump (i.e., with abeating heart), under fluoroscopy and/or echo guidance.

It is to be further noted that systems 10, 300, 320, 330, 110, 1700 and2600, and catheters 12, 14, 340, 1012 and 1014 may be advanced using a(1) trans-septal procedure in which the system is advanced throughvasculature of the patient at any suitable access location (e.g.,femoral vein), (2) a minimally-invasive transapical approach (as shownin FIG. 31), (3) a minimally-invasive transatrial approach (e.g., anintercostal approach), or (4) a surgical, open-heart approach.Furthermore, for some applications, the systems described herein are notsteerable and may comprise straight elements (e.g., in a surgical,open-heart procedure).

It is to be further noted that systems 10, 300, 320, 330, 110, 1700 and2600, and catheters 12, 14, 340, 1012 and 1014 for repairing a dilatedannulus of the patient may be used to treat any cardiac valve of thepatient, e.g., the aortic valve, the pulmonary valve, the mitral valve,and the tricuspid valve. It is to be still further noted that systemsdescribed herein for treatment of valves may be used to treat otherannular muscles within the body of the patient. For example, the systemsdescribed herein may be used in order to treat a sphincter muscle withina stomach of the patient.

It is further noted that the scope of the present invention includes theuse systems 10, 300, 320, 330, 110, 1700 and 2600, and catheters 12, 14,340, 1012 and 1014 (or subcomponents thereof) and methods describedhereinabove on any suitable tissue of the patient (e.g., stomach tissue,urinary tract, and prostate tissue).

Additionally, the scope of the present invention includes applicationsdescribed in one or more of the following:

-   -   U.S. patent application Ser. No. 12/435,291 to Maisano et al.,        entitled, “Adjustable repair chords and spool mechanism        therefor,” filed on May 4, 2009, which published as US Patent        Application Publication 2010/0161041 (now, U.S. Pat. No.        8,147,542);    -   U.S. patent application Ser. No. 12/437,103 to Zipory et al.,        entitled, “Annuloplasty ring with intra-ring anchoring,” filed        on May 7, 2009, which published as US Patent Application        Publication 2010/0286767 (now, U.S. Pat. No. 8,715,342);    -   U.S. patent application Ser. No. 12/548,991 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        Aug. 27, 2009, which published as US Patent Application        Publication 2010/0161042 (nom, U.S. Pat. No. 8,808,368);    -   PCT Patent Application PCT/IL2009/001209 to Cabiri et al.,        entitled, “Adjustable annuloplasty devices and mechanisms        therefor,” filed on Dec. 22, 2009, which published as PCT        Publication WO 10/073246;    -   PCT Patent Application PCT/IL2010/000357 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        May 4, 2010, which published as WO 10/128502; and/or    -   PCT Patent Application PCT/IL2010/000358 to Zipory et al.,        entitled, “Deployment techniques for annuloplasty ring and        over-wire rotation tool,” filed on May 4, 2010, which published        as WO 10/128503.

All of these applications are incorporated herein by reference.Techniques described herein can be practiced in combination withtechniques described in one or more of these applications.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

1-61. (canceled)
 62. Apparatus for percutaneous access to a body of apatient, comprising: a steerable tube, having a proximal sectionincluding a proximal end, a distal section including a distal end, and acentral longitudinal axis between the proximal end and the distal end,the tube being shaped to define: a primary lumen between the proximalend and the distal end, and two secondary lumens, each of the secondarylumens extending longitudinally from the proximal section to the distalsection; two wires, each of the wires extending from the distal sectionproximally through a respective one of the secondary lumens; a handle,coupled to the proximal section of the tube, and comprising a steeringknob that is coupled to the wires such that rotation of the knob adjustsa degree of tension in the wires; a pull ring: coupled to the distalsection of the tube such that the pull ring circumscribes thelongitudinal axis at the distal section of the tube, and defining tworecesses, a distal end portion of each wire being disposed in arespective one of the recesses; and at least one cap, bridging therecesses and the distal end portion of the wires.
 63. The apparatusaccording to claim 62, wherein the pull ring has a length along thelongitudinal axis of 2.5-2.6 mm.
 64. The apparatus according to claim62, wherein the tube has an inner diameter of 6.5-7 mm and an outerdiameter of 7-9 mm.
 65. The apparatus according to claim 62, wherein thetube has an inner diameter of 4.7-5.3 mm and an outer diameter of6.3-6.9 mm.
 66. The apparatus according to claim 62, wherein the tubehas a length of 700-1200 mm.
 67. The apparatus according to claim 62,wherein the tube has a length 1000-1500 mm.
 68. The apparatus accordingto claim 62, wherein the secondary lumens are spaced from each other by180 degrees around the primary lumen.
 69. The apparatus according toclaim 62, wherein the distal end portion of each wire is welded to thepull ring.
 70. The apparatus according to claim 62, wherein the at leastone cap is welded to the pull ring.
 71. The apparatus according to claim62, wherein the at least one cap is welded to the wires.
 72. Theapparatus according to claim 62, further comprising an implant,advanceable though the primary lumen of the tube.
 73. The apparatusaccording to claim 62, wherein the tube comprises a friction-reducingliner that lines the secondary lumens.
 74. The apparatus according toclaim 73, wherein the friction-reducing liner comprisespolytetrafluoroethylene.
 75. The apparatus according to claim 62,wherein the distal section has a durometer of 45D-63D.
 76. The apparatusaccording to claim 75, wherein the distal section has a length of 4-5mm.
 77. The apparatus according to claim 75, wherein the distal sectionhas a length of 3.5-4.5 mm.
 78. The apparatus according to claim 75,wherein the tube has a bending section proximal to the distal section,the bending section having a lower durometer than the distal section.79. The apparatus according to claim 78, wherein the bending section hasa durometer of 25-45D.
 80. The apparatus according to claim 78, whereinthe bending section has a length of 22-27 mm.
 81. The apparatusaccording to claim 78, wherein the bending section has a length of 60-70mm.
 82. The apparatus according to claim 78, wherein the tube has atransition section longitudinally between the distal section and thebending section, the transition section having a durometer of 63D-72D.83. The apparatus according to claim 82, wherein the transition sectionhas a length of 1-2 mm.
 84. The apparatus according to claim 82, whereinthe transition section is immediately proximal to the distal section,and immediately distal to the bending section.
 85. The apparatusaccording to claim 82, wherein, proximal to the bending section, thetube has a uniform durometer section having a durometer of 63-72D. 86.The apparatus according to claim 85, wherein the uniform durometersection has a length of 770-860 mm.
 87. The apparatus according to claim85, wherein the uniform durometer section has a length of 900-1400 mm.